Method of robotically driving a multi catheter assembly above the aortic arch

ABSTRACT

A method of achieving supra aortic access includes the steps of providing an assembly including a guidewire, an access catheter and a guide catheter, coaxially moveably assembled into a single multi-catheter assembly, coupling the assembly to a drive system, driving the assembly to an aortic arch, and advancing the access catheter to achieve supra-aortic access to a branch vessel off of the aortic arch.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57. Thepresent application is a continuation-in-part of U.S. application Ser.No. 17/816,669, filed on Aug. 1, 2022, titled METHOD OF SUPRA-AORTICACCESS FOR A NEUROVASCULAR PROCEDURE, the entire content of which isincorporated by reference herein for all purposes and forms a part ofthis specification.

BACKGROUND Field

The present application relates to neurovascular procedures, and moreparticularly, to catheter assemblies and robotic control systems forneurovascular site access.

Description of the Related Art

A variety of neurovascular procedures can be accomplished via atransvascular access, including thrombectomy, diagnostic angiography,embolic coil deployment and stent placement. However, the delivery ofneurovascular care is limited or delayed by a variety of challenges. Forexample, there are not enough trained interventionalists and centers tomeet the current demand for neurointerventions. Neuro interventions aredifficult, with complex set up requirements and demands on the surgeon'sdexterity. With two hands, the surgeon must exert precise control over3-4 coaxial catheters plus manage the fluoroscopy system and patientposition. Long, tortuous anatomy, requires delicate, precise maneuvers.Inadvertent catheter motion can occur due energy storage and releasecaused by frictional interplay between coaxial shafts and the patient'svasculature. Supra-aortic access necessary to reach the neurovascular ischallenging to achieve, especially Type III arches. Once supra-aorticaccess is achieved, adapting the system for neurovascular treatments istime consuming and requires guidewire and access catheter removal andaddition of a procedure catheter (and possibly one or more additionalcatheters) to the stack.

Thus, there remains a need for a supra-aortic access and neurovascularsite access system that addresses some or all these challenges andincreases the availability of neurovascular procedures. Preferably, thesystem is additionally capable of driving devices further distallythrough the supra-aortic access to accomplish procedures in theintracranial vessels.

SUMMARY

There is provided in accordance with one aspect of the presentdisclosure a supra-aortic access robotic control system. The systemcomprises a guidewire hub configured to adjust each of an axial positionand a rotational position of a guidewire; a guide catheter hubconfigured to adjust a guide catheter in an axial direction; and anaccess catheter hub configured to adjust each of an axial position and arotational position of an access catheter. The access catheter hub mayalso laterally deflect a distal deflection zone of the access catheter.The guidewire hub may additionally be configured to laterally deflect adistal portion of the guidewire.

There may also be provided a procedure catheter hub configured tomanipulate a procedure catheter. Following robotic placement of theguidewire, access catheter and guide catheter such that the guidecatheter achieves supra aortic access, the guidewire and access cathetermay be proximally withdrawn and the procedure catheter advanced throughand beyond the guide catheter, with or without guidewire support (saidguidewire may be smaller in diameter and/or more flexible than theguidewire used to gain supra aortic access), to reach a more distalneurovascular treatment site. The procedure catheter may be anaspiration catheter; an embolic deployment catheter; a stent deploymentcatheter; a flow diverter deployment catheter, an access catheter; adiagnostic angiographic catheter; a guiding catheter, an imagingcatheter, a physiological sensing/measuring catheter, an infusion orinjection catheter, an ablation catheter, an RF ablation catheter orguidewire, a balloon catheter, or a microcatheter used to deliver astent retriever, a balloon catheter or a stent retriever.

The control system may further comprise a driven magnet on each of aguidewire hub, an access catheter hub and a guide catheter hub,configured to cooperate with corresponding drive magnets such that thedriven magnet moves in response to movement of the corresponding drivemagnet. The drive magnets may each be independently axially movablycarried by a support table. The drive magnets may be located outside ofthe sterile field, separated from the driven magnets by a barrier, andthe driven magnets may within the sterile field. The barrier maycomprise a tray made from a thin polymer membrane, or any membrane ofnon-ferromagnetic material.

The control system may further comprise a control console which may beconnected to the support table or may be located remotely from thesupport table. The position of each driven magnet and corresponding hubis movable in response to manual manipulation of a guidewire drivecontrol, access catheter drive control, or procedure catheter drivecontrol on the console or on a particular controller not associated withthe console.

The control system may further comprise a processor for controlling theposition of the drive magnets. The processor may be in wiredcommunication with the control console, or in wireless communicationwith the control console. The driven magnets may be configured to remainengaged with the corresponding drive magnets until application of anaxial disruption force of at least about 300 grams.

There is also provided a robotically driven interventional device. Thedevice comprises an elongate, flexible body, having a proximal end and adistal end. A hub is provided on the proximal end. At least onerotatable roller is provided on a first surface of the hub; and at leastone magnet is provided on the first surface of the hub. The roller mayextend further away from the first surface than the magnet. The hub maybe further provided with at least a second roller.

Any of the guidewire hub, access catheter hub and procedure catheter hubmay be further provided with a rotational drive, for rotating thecorresponding interventional device with respect to the hub. The hub maybe further provided with an axial drive mechanism to distally advance orproximally retract a control element extending axially through theinterventional device, to adjust a characteristic such as shape orflexibility of the interventional device. In some embodiments, at leastone control element may be an axially movable tubular body or fiber,ribbon, or wire such as a pull wire extending through the interventionaldevice to, for example, a distal deflection zone. In some embodiments,any number of control elements may be advanced, retracted, or otherwisemoved in a similar manner.

There is also provided a control system for controlling movement ofinterventional devices. In one configuration, the control systemcomprises a guidewire control, configured to control axial travel androtation of a guidewire; an access catheter control, configured tocontrol axial and rotational movement of an access catheter; and a guidecatheter control, configured to control axial movement and/or rotationof a guide catheter.

The control system may further comprise a deflection control, configuredto control deflection of the access catheter or procedure catheter, andmay be configured for wired or wireless communication with a roboticcatheter drive system.

The control system may be configured to independently control the threeor more hubs in a variety of modes. For example, two or more hubs may beselectively ganged together so that they drive the respective devicessimultaneously and with the same motion. Alternatively, the controlsystem may be configured to drive respective devices simultaneously butwith different motions.

The control system may further comprise a physician interface foroperating the control system. The physician interface may be carried bya support table having a robotic interventional device drive system.Alternatively, the physician interface for operating the control systemmay be carried on a portable, handheld device or desktop computer, andmay be located in the same room as the patient, the same facility as thepatient, or in a remote facility.

The control system may further comprise a graphical user interface withat least one display for indicating the status of at least one deviceparameter, and/or indicating the status of at least one patientparameter.

There is also provided a sterile packaging assembly for transportinginterventional devices to a robotic surgery site. The packaging assemblymay comprise a base and a sterile barrier configured to enclose asterile volume. At least one interventional device may be providedwithin the sterile volume, the device including a hub and an elongateflexible body. The hub may include at least one magnet and at least oneroller configured to roll on the base.

In one implementation, the sterile barrier is removably attached to thebase to define the enclosed volume between the sterile barrier and thebase. In another implementation, the sterile barrier is in the form of atubular enclosure for enclosing the sterile volume. The tubularenclosure may surround the base and the at least one interventionaldevice, which are within the sterile volume.

The hub may be oriented within the packaging such that the roller andthe magnet face the base. Alternatively, the base may be in the form ofa tray having an elongate central axis. An upper, sterile field side ofthe tray may have an elongate support surface for supporting andpermitting sliding movement of one or more hubs. At least one andoptionally two elongate trays may be provided, extending parallel to thecentral axis. At least one hub and interventional device may be providedin the tray, and the sterile tray with sterile hub and interventionaldevice may be positioned in a sterile volume defined by a sterilebarrier.

The base may be configured to reside on a support table adjacent apatient, with an upper surface of the base within a sterile field and alower surface of the base outside of the sterile field.

Any of the hubs disclosed herein may further comprise a fluid injectionport and/or a wireless RF transceiver for communications and/or powertransfer. The hub may comprise a visual indicator, for indicating thepresence of a clot. In some embodiments, the hub may also comprise wiredelectrical communications and power port. The visual indicator maycomprise a clot chamber having a transparent window. A filter may beprovided in the clot chamber.

Any of the hubs disclosed herein may further comprise a sensor fordetecting a parameter of interest such as the presence of a clot. Thesensor, in some instances, may be positioned on a flexible body. Thesensor may comprise a pressure sensor or an optical sensor. In someembodiments, the sensor may comprise one or more of a force sensor, apositioning sensor, a temperature sensor, and/or an oxygen sensor. Insome embodiments, the sensor may comprise a Fiber Bragg grating sensor.For example, a Fiber Bragg grating sensor (e.g., an optical fiber) maydetect strain locally that can facilitate the detection and/ordetermination of force being applied. The device may further include aplurality of sensors. The plurality of sensors may each comprise one ormore of any type of sensor disclosed herein. In some embodiments, aplurality (e.g., 3 or more) of sensors (e.g., Fiber Bragg gratingsensors) may be distributed around a perimeter to facilitate thedetection and/or determination of shape. The position of the device, insome instance, may be determined through the use of one or more sensorsto detect and/or determine the position. For example, one or moreoptical encoders may be located in or proximate to one or more themotors that drive linear motion such that the optical encoders maydetermine a position.

There is also provided a method of performing a neurovascular procedure,in which a first phase includes robotically achieving supra-aorticaccess, and a second phase includes manually or robotically performing aneurovascular procedure via the supra-aortic access. The methodcomprises the steps of providing an access catheter having an accesscatheter hub; coupling the access catheter hub to a hub adapter movablycarried by a support table; driving the access catheter in response tomovement of the hub adapter along the table until the access catheter ispositioned to achieve supra-aortic access. The access catheter andaccess catheter hub may then be decoupled from the hub adapter; and aprocedure catheter hub having a procedure catheter may then be coupledto the hub adapter.

The method may additionally comprise advancing the procedure catheterhub to position a distal end of the procedure catheter at aneurovascular treatment site. The driving the access catheter step maycomprise driving the access catheter distally through a guide catheter.The driving the access catheter step may include the step of laterallydeflecting a distal region of the access catheter to achievesupra-aortic access. In some embodiments, the driving the accesscatheter step may also include rotating the access catheter.

There is also provided a method of performing a neurovascular procedure,comprising the steps of providing an access assembly comprising aguidewire, access catheter and guide catheter. The access assembly maybe releasably coupled to a robotic drive system. The access assembly maybe driven by the robotic drive system to achieve access to a desiredpoint, such as to achieve supra-aortic access. The guidewire and theaccess catheter may then be decoupled from the access assembly, leavingthe guide catheter in place. A procedure assembly may be provided,comprising at least a guidewire and a first procedure catheter. Theprocedure assembly may be releasably coupled to the robotic drivesystem; and a neurovascular procedure may be accomplished using theprocedure assembly. A second procedure catheter may also be provided,for extending through the first procedure catheter to a treatment site.

The coupling the access assembly step may comprise magnetically couplinga hub on each of the guidewire, access catheter and guide catheter, toseparate corresponding couplers carrying corresponding drive magnetsindependently movably carried by the drive table. The procedure assemblymay comprise a guidewire, a first catheter and a second catheter. Theguidewire and first catheter may be positioned concentrically within thesecond catheter. The procedure assembly may be advanced as a unitthrough at least a portion of the length of the guide catheter, and theprocedure may comprise a neurovascular thrombectomy.

There is also provided a method of performing a neurovascular procedure.The method includes the steps of providing a multi-catheter assemblyincluding an access catheter, a guide catheter, and a procedurecatheter, coupling the assembly to a robotic drive system, driving theassembly to achieve supra-aortic access, driving a subset of theassembly to a neurovascular site, wherein the subset includes the guidecatheter and the procedure catheter, proximally removing the accesscatheter, and performing a neurovascular procedure using the procedurecatheter.

The neurovascular procedure can include a neurovascular thrombectomy.The assembly may further include a guidewire, wherein each of theguidewire, the access catheter, the guide catheter, and the procedurecatheter are configured to be adjusted by a respective hub. Coupling theassembly to the robotic drive system can include magnetically coupling afirst hub of the guidewire to a first drive magnet, magneticallycoupling a second hub of the access catheter to a second drive magnet,magnetically coupling a third hub of the guide catheter to a third drivemagnet, and magnetically coupling a fourth hub of the procedure catheterto a fourth drive magnet. The first drive magnet, the second drivemagnet, the third drive magnet, and the fourth drive magnet can each beindependently movably carried by a drive table. The procedure cathetercan be an aspiration catheter. The procedure catheter can be an embolicdeployment catheter. The procedure catheter can be a stent deploymentcatheter. The procedure catheter can be a flow diverter deploymentcatheter. The procedure catheter can be a diagnostic angiographiccatheter. The procedure catheter can be a stent retriever catheter. Theprocedure catheter can be a clot retriever. The procedure catheter canbe a balloon catheter. The procedure catheter can be a catheter tofacilitate percutaneous valve repair or replacement. The procedurecatheter can be an ablation catheter.

There is also provided a method of performing a neurovascular procedure.The method includes the steps of providing an assembly including aguidewire, an access catheter, a guide catheter, and a procedurecatheter coaxially moveably assembled into a single multi-catheterassembly, coupling the assembly to a drive system, driving the assemblyto achieve supra-aortic access, driving a subset of the assembly to anintracranial site, wherein the subset includes the guidewire, the guidecatheter, and the procedure catheter, and performing a neurovascularprocedure using the subset of the assembly.

Each of the guidewire, the access catheter, the guide catheter, and theprocedure catheter can be configured to be adjusted by a respective hub.Coupling the assembly to the drive system can include magneticallycoupling a first hub of the guidewire to a first drive magnet,magnetically coupling a second hub of the access catheter to a seconddrive magnet, magnetically coupling a third hub of the guide catheter toa third drive magnet, and magnetically coupling a fourth hub of theprocedure catheter to a fourth drive magnet. The drive system can be arobotic drive system, and the first drive magnet, the second drivemagnet, the third drive magnet, and the fourth drive magnet can each beindependently movably carried by a drive table associated with therobotic drive system. The first drive magnet, the second drive magnet,the third drive magnet, and the fourth drive magnet can each beindependently movably carried by a drive table.

There is also provided a method of performing a neurovascular procedure.The method includes providing an assembly including a guidewire having aguidewire hub, an access catheter having an access catheter hub, and aguide catheter having a guide catheter hub. The method also includescoupling the guidewire hub to a first hub adapter, the access catheterhub to a second hub adapter, and the guide catheter hub to a third hubadapter, wherein each of the first hub adapter, the second hub adapterand the third hub adapter is movably carried by a support table. Themethod also includes driving the assembly in response to movement ofeach of the first hub adapter, the second hub adapter and the third hubadapter along the support table until the assembly is positioned toachieve supra-aortic vessel access.

The method can include the step of driving a subset of the assemblyalong the support table until the subset of the assembly is positionedto perform a neurovascular procedure at a neurovascular treatment site,wherein the subset of the assembly includes the guidewire, the guidecatheter, and a procedure catheter. The neurovascular procedure caninclude a thrombectomy. Coupling the guidewire hub to the first hubadapter can include magnetically coupling the guidewire hub to a firstdrive magnet. Coupling the access catheter hub to the second hub adaptercan include magnetically coupling the access catheter hub to a seconddrive magnet. Coupling the guide catheter hub to the third hub adaptercan include magnetically coupling the guide catheter hub to a thirddrive magnet. The first drive magnet, the second drive magnet and thethird drive magnets can be independently movably carried by the supporttable. The first drive magnet can be coupled to a first driven magnetacross a sterile field barrier. The second drive magnet can be coupledto a second driven magnet across the sterile field barrier. The thirddrive magnet can be coupled to a third driven magnet across the sterilefield barrier. Coupling the guidewire hub to the first hub adapter caninclude mechanically coupling the guidewire hub to a first drive.Coupling the access catheter hub to the second hub adapter can includemechanically coupling the access catheter hub to a second drive.Coupling the guide catheter hub to the third hub adapter can includemechanically coupling the guide catheter hub to a third drive. Theguidewire and the guide catheter can be advanced as a unit along atleast a portion of a length of the access catheter after supra-aorticaccess is achieved. The guidewire hub can be configured to adjust anaxial position and a rotational position of the guidewire. The assemblycan further include a procedure catheter having a procedure catheterhub. The procedure catheter hub can be configured to adjust an axialposition and a rotational position of the procedure catheter. Theprocedure catheter hub can be further configured to laterally deflect adistal deflection zone of the procedure catheter. The guidewire hub canbe configured to adjust an axial position and a rotational position ofthe guidewire. The procedure catheter hub can be configured to adjust anaxial position and a rotational position of the procedure catheter. Theguide catheter hub can be configured to adjust an axial position of theguide catheter. The access catheter hub can be configured to adjust anaxial position and a rotational position of the access catheter. Theprocedure catheter hub can be further configured to laterally deflect adistal deflection zone of the procedure catheter. The access catheterhub can be further configured to laterally deflect a distal deflectionzone of the access catheter. The guide catheter hub can be configured toadjust an axial position of the guide catheter. The access catheter hubcan be configured to adjust an axial position and a rotational positionof the access catheter. The access catheter hub can be furtherconfigured to laterally deflect a distal deflection zone of the accesscatheter.

There is also provided a drive system for achieving supra-aortic accessand neurovascular treatment site access. The system includes a guidewirehub configured to adjust an axial position and a rotational position ofa guidewire, a procedure catheter hub configured to adjust an axialposition and a rotational position of a procedure catheter, a guidecatheter hub configured to adjust an axial position of a guide catheter,and an access catheter hub configured to adjust an axial position and arotational position of an access catheter, the access catheter furtherconfigured to laterally deflect a distal deflection zone of the accesscatheter.

The procedure catheter hub can be further configured to laterallydeflect a distal deflection zone of the procedure catheter. Theguidewire hub can be configured to couple to a guidewire hub adapter bymagnetically coupling the guidewire hub to a first drive magnet. Theaccess catheter hub can be configured to couple to an access catheterhub adapter by magnetically coupling the access catheter hub to a seconddrive magnet. The guide catheter hub can be configured to couple to aguide catheter hub adapter by magnetically coupling the guide catheterhub to a third drive magnet. The procedure catheter hub can beconfigured to couple to a procedure catheter hub adapter by magneticallycoupling the procedure catheter hub to a fourth drive magnet. The firstdrive magnet, the second drive magnet, the third drive magnet, and thefourth drive magnet can be independently movably carried by a drivetable. The system can include first driven magnet on the guidewire hubconfigured to cooperate with the first drive magnet such that the firstdriven magnet moves in response to movement of the first drive magnet.The first drive magnet can be configured to move outside of a sterilefield while separated from the first driven magnet by a sterile fieldbarrier while the first driven magnet is within the sterile field. Aposition of the first drive magnet can be movable in response tomanipulation of a procedure drive control on a control console inelectrical communication with the drive table. The system can include asecond driven magnet on the access catheter hub configured to cooperatewith the second drive magnet such that the second driven magnet isconfigured to move in response to movement of the second drive magnet,wherein the second drive magnet is configured to move outside of thesterile field while separated from the second driven magnet by thebarrier while the second driven magnet is within the sterile field. Thesystem can include a third driven magnet on the guide catheter hubconfigured to cooperate with the third drive magnet such that the thirddriven magnet is configured to move in response to movement of the thirddrive magnet, wherein the third drive magnet is configured to moveoutside of the sterile field while separated from the third drivenmagnet by the barrier while the third driven magnet is within thesterile field. The system can include a fourth driven magnet on theprocedure catheter hub configured to cooperate with the fourth drivemagnet such that the fourth driven magnet is configured to move inresponse to movement of the fourth drive magnet, wherein the fourthdrive magnet is configured to move outside of the sterile field whileseparated from the fourth driven magnet by the barrier while the fourthdriven magnet is within the sterile field. The procedure catheter can bean aspiration catheter. The procedure catheter can be an embolicdeployment catheter. The procedure catheter can be a stent deploymentcatheter. The procedure catheter can be a flow diverter deploymentcatheter. The procedure catheter can be a diagnostic angiographiccatheter. The procedure catheter can be a stent retriever catheter. Theprocedure catheter can be a balloon catheter. The procedure catheter canbe a catheter to facilitate percutaneous valve repair or replacement.The procedure catheter can be an ablation catheter.

There is also provided method of achieving supra-aortic access andneurovascular treatment site access. The method includes the steps ofproviding a drive system including a guidewire hub configured to adjustan axial position and a rotational position of a guidewire, a procedurecatheter hub configured to adjust an axial position and a rotationalposition of a procedure catheter; a guide catheter hub configured toadjust an axial position of a guide catheter, and an access catheter hubconfigured to adjust an axial position and a rotational position of anaccess catheter, the access catheter further configured to laterallydeflect a distal deflection zone of the access catheter, and moving atleast one of the guidewire hub, the procedure catheter hub, the guidecatheter hub, and the access catheter hub to drive movement of at leastone of the guidewire, the procedure catheter, the guide catheter, andthe access catheter. The method can further include controlling theprocedure catheter hub to laterally deflect a distal deflection zone ofthe procedure catheter.

There is also provided a method of achieving supra aortic access. Themethod includes the steps of providing an assembly including aguidewire, an access catheter and a guide catheter, coaxially moveablyassembled into a single multi-catheter assembly, coupling the assemblyto a drive system, driving the assembly to an aortic arch, and advancingthe access catheter to achieve supra-aortic access to a branch vesseloff of the aortic arch.

The method can further include driving a subset of the assembly to anintracranial site, and performing a neurovascular procedure using thesubset of the assembly. The subset can include the guidewire, the guidecatheter, and a procedure catheter. The procedure catheter can be anaspiration catheter. The procedure catheter can be an embolic deploymentcatheter. The procedure catheter can be a stent deployment catheter. Theprocedure catheter can be a flow diverter deployment catheter. Theprocedure catheter can be a diagnostic angiographic catheter. Theprocedure catheter can be a stent retriever catheter. The procedurecatheter can be a clot retriever. The procedure catheter can be aballoon catheter. The procedure catheter can be a catheter to facilitatepercutaneous valve repair or replacement. The procedure catheter can bean ablation catheter. The intracranial procedure can include anintracranial thrombectomy. The neurovascular procedure can include aneurovascular thrombectomy. At least one of the guidewire, the accesscatheter, and the guide catheter can include a hub configured to coupleto a robotic drive system. Coupling the assembly to the drive system caninclude magnetically coupling a guide catheter hub to the drive system.Coupling the assembly to the drive system can include mechanicallycoupling a guide catheter hub to the drive system. The drive system canbe a robotic drive system, and at least a first drive magnet, a seconddrive magnet, and a third drive magnet are each independently movablycarried by a drive table associated with the robotic drive system.

There is also provided a method of priming an interventional deviceassembly. The method includes providing the interventional deviceassembly, the interventional device assembly including a firstinterventional device coupled to a first hub and a second interventionaldevice coupled to a second hub arranged in a concentric stack, thesecond interventional device being positioned within a lumen of thefirst interventional device. The method includes coupling theinterventional device assembly to a drive system while arranged in theconcentric stack, axially advancing the first interventional device andthe first hub relative to the second hub to decrease a depth ofinsertion of the second interventional device within the lumen of thefirst interventional device while maintaining a distal end of the secondinterventional device within the lumen of the first interventionaldevice, and flushing the first interventional device with fluid afterdecreasing the depth of insertion of the second interventional devicewithin the lumen of the first interventional device.

The first interventional device can be a first catheter and the secondinterventional device can be a second catheter. The first catheter canbe a guide catheter, the first hub can be a guide catheter hub, thesecond catheter can be a procedure catheter, and the second hub can be aprocedure catheter hub. The interventional device assembly can includean access catheter coupled to an access catheter hub arranged in theconcentric stack, the access catheter being positioned within a lumen ofthe procedure catheter. The method can include returning the guidecatheter to an initial position relative to the procedure catheter afterflushing the guide catheter with fluid, axially advancing the guidecatheter, the guide catheter hub, the procedure catheter, and theprocedure catheter hub relative to the access catheter hub to decrease adepth of insertion of the access catheter within the lumen of theprocedure catheter while maintaining a distal end of the access catheterwithin the lumen of the procedure catheter and substantially maintaininga relative position between the guide catheter and the procedurecatheter, and flushing the procedure catheter with fluid afterdecreasing the depth of insertion of the access catheter within thelumen of the procedure catheter. The interventional device assembly caninclude a guidewire coupled to a guidewire hub arranged in theconcentric catheter stack, the guidewire being positioned within a lumenof the access catheter. The method can include returning the guidecatheter and the procedure catheter to an initial position relative tothe access catheter after flushing the procedure catheter with fluid,axially advancing the guide catheter, the guide catheter hub, theprocedure catheter, the procedure catheter hub, the access catheter, andthe access catheter hub relative to the guidewire hub to decrease adepth of insertion of the guidewire within the lumen of the accesscatheter while maintaining a distal end of the guidewire within thelumen of the access catheter and substantially maintaining relativepositions between the guide catheter, the procedure catheter, and theaccess catheter, and flushing the access catheter with fluid afterdecreasing the depth of insertion of the guidewire within the lumen ofthe access catheter. The method can include flushing the second catheterwith fluid, wherein the steps of flushing the first catheter andflushing the second catheter are performed simultaneously. The drivesystem can be a robotic drive system. The fluid can be saline. The firstinterventional device can be a catheter and the second interventionaldevice can be a guidewire. The method can include reciprocally moving atleast one of the first interventional device and the secondinterventional device relative to the other of the first interventionaldevice and the second interventional device while flushing the firstinterventional device with fluid after decreasing the depth of insertionof the second interventional device within the lumen of the firstinterventional device.

There is also provided a method of priming a multi catheter assembly.The method includes providing the multi catheter assembly, the multicatheter assembly including a guidewire, an access catheter, a procedurecatheter, and a guide catheter in a concentric stacked configuration,coupling the multi catheter assembly to a drive system, translating theguide catheter distally relative to the guidewire, the access catheter,and the procedure catheter, flushing the guide catheter with fluid, andtranslating the guide catheter proximally towards the guidewire, theaccess catheter, and the procedure catheter.

The method can include translating the procedure catheter and the guidecatheter distally relative to the guidewire and the access catheter,flushing the procedure catheter with fluid, and translating theprocedure catheter and the guide catheter proximally towards theguidewire and the access catheter. The method can include translatingthe access catheter, the procedure catheter, and the guide catheterdistally relative to the guidewire, flushing the access catheter withfluid, and translating the access catheter, the procedure catheter, andthe guide catheter proximally towards the guidewire. The fluid can besaline. The drive system can be a robotic drive system. The guidewirecan coupled to a guidewire hub. The access catheter can be coupled to anaccess catheter hub. The procedure catheter can be coupled to aprocedure catheter hub. The guide catheter can be coupled to a guidecatheter hub. In the concentric stacked configuration, the procedurecatheter is positioned within a lumen of the guide catheter, the accesscatheter is positioned within a lumen of the procedure catheter, and theguidewire is positioned within a lumen of the access catheter. Themethod can include reciprocally moving at least one of the guidecatheter and the procedure catheter relative to the other of the guidecatheter and the procedure catheter while flushing the guide catheterwith fluid.

There is also provided a method of priming an interventional deviceassembly. The method includes providing the interventional deviceassembly, the interventional device assembly comprising a firstinterventional device and a second interventional device, the secondinterventional device being positioned within the first interventionaldevice, and reciprocally moving at least one of the first interventionaldevice and the second interventional device relative to the other of thefirst interventional device and the second interventional device whileflushing a lumen between the first interventional device and the secondinterventional device with fluid to remove microbubbles from the lumen.

Reciprocally moving at least one of the first interventional device andthe second interventional device relative to the other of the firstinterventional device and the second interventional device can includeaxially reciprocally moving at least one of the first interventionaldevice and the second interventional device relative to the other of thefirst interventional device and the second interventional device.Reciprocally moving at least one of the first interventional device andthe second interventional device relative to the other of the firstinterventional device and the second interventional device can furtherinclude rotationally reciprocally moving at least one of the firstinterventional device and the second interventional device relative tothe other of the first interventional device and the secondinterventional device. Axially reciprocally moving at least one of thefirst interventional device and the second interventional devicerelative to the other of the first interventional device and the secondinterventional device can include axially reciprocally moving at leastone of the first interventional device and the second interventionaldevice relative to the other of the first interventional device and thesecond interventional device over a stroke length between about 10 mmand about 250 mm. Axially reciprocally moving at least one of the firstinterventional device and the second interventional device relative tothe other of the first interventional device and the secondinterventional device can include axially reciprocally moving at leastone of the first interventional device and the second interventionaldevice relative to the other of the first interventional device and thesecond interventional device over a stroke length between about 25 mmand about 125 mm. Axially reciprocally moving at least one of the firstinterventional device and the second interventional device relative tothe other of the first interventional device and the secondinterventional device can include axially reciprocally moving at leastone of the first interventional device and the second interventionaldevice relative to the other of the first interventional device and thesecond interventional device over a stroke length greater than 20 mm.Axially reciprocally moving at least one of the first interventionaldevice and the second interventional device relative to the other of thefirst interventional device and the second interventional device caninclude axially reciprocally moving at least one of the firstinterventional device and the second interventional device relative tothe other of the first interventional device and the secondinterventional device at a reciprocation frequency of no more than about5 Hz. The reciprocation frequency can be no more than about 1 Hz.Reciprocally moving at least one of the first interventional device andthe second interventional device relative to the other of the firstinterventional device and the second interventional device can includerotationally reciprocally moving at least one of the firstinterventional device and the second interventional device relative tothe other of the first interventional device and the secondinterventional device. Reciprocally moving at least one of the firstinterventional device and the second interventional device relative tothe other of the first interventional device and the secondinterventional device can include reciprocally moving both the firstinterventional device and the second interventional device relative toone another. Reciprocally moving at least one of the firstinterventional device and the second interventional device relative tothe other of the first interventional device and the secondinterventional device can be performed by a robotic drive table. Thefirst interventional device can be a first catheter and the secondinterventional device can be a second catheter. The first interventionaldevice can be a catheter and the second interventional device can be aguidewire.

There is also provided a method of priming a multi catheter assembly.The method includes providing the multi catheter assembly, the multicatheter assembly including a guidewire, an access catheter, a procedurecatheter, and a guide catheter arranged in a concentric catheter stack,wherein the guidewire is positioned within a lumen of the accesscatheter, the access catheter is positioned within a lumen of theprocedure catheter, and the procedure catheter is positioned within alumen of the guide catheter, and flushing the guide catheter with salinewhile reciprocally moving at least one of the guide catheter and theprocedure catheter relative to the other of the guide catheter and theprocedure catheter.

Flushing the guide catheter with saline while reciprocally moving atleast one of the guide catheter and the procedure catheter relative tothe other of the guide catheter and the procedure catheter can includeaxially reciprocally moving, rotationally reciprocally moving, or bothaxially and rotationally reciprocally moving at least one of the guidecatheter and the procedure catheter relative to the other of the guidecatheter and the procedure catheter. The method can include flushing theprocedure catheter with saline while reciprocally moving at least one ofthe procedure catheter and the access catheter relative to the other ofthe procedure catheter and the access catheter. Flushing the procedurecatheter with saline while reciprocally moving at least one of theprocedure catheter and the access catheter relative to the other of theprocedure catheter and the access catheter can include axiallyreciprocally moving, rotationally reciprocally moving, or both axiallyand rotationally reciprocally moving at least one of the procedurecatheter and the access catheter relative to the other of the procedurecatheter and the access catheter. The method can include flushing theaccess catheter with saline while reciprocally moving at least one ofthe access catheter and the guidewire relative to the other of theaccess catheter and the guidewire. Flushing the access catheter withsaline while reciprocally moving at least one of the access catheter andthe guidewire can include axially reciprocally moving, rotationallyreciprocally moving, or both axially and rotationally reciprocallymoving at least one of the access catheter and the guidewire relative tothe other of the access catheter and the guidewire. The steps offlushing the guide catheter with saline while reciprocally moving atleast one of the guide catheter and the procedure catheter relative tothe other of the guide catheter and the procedure catheter, flushing theprocedure catheter with saline while reciprocally moving at least one ofthe procedure catheter and the access catheter relative to the other ofthe procedure catheter and the access catheter, and flushing the accesscatheter with saline while reciprocally moving at least one of theaccess catheter and the guidewire relative to the other of the accesscatheter and the guidewire can be performed simultaneously.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic perspective view of an interventional setup havingan imaging system, a patient support table, and a robotic drive systemin accordance with the present disclosure.

FIG. 2 is a longitudinal cross section showing the concentricrelationship between a guidewire having two degrees of freedom, anaccess catheter having 3 degrees of freedom and a guide catheter havingone degree of freedom.

FIG. 3A is an exploded schematic view of interventional device hubsseparated from a support table by a sterile barrier.

FIGS. 3B-3F show an alternate sterile barrier in the form of a shippingtray having one or more storage channels for carrying interventionaldevices.

FIGS. 3G-3K show embodiments of an alternate sterile barrier having aconvex drive surface.

FIGS. 3L and 3M depict an example of a hub that may be used with thesterile barriers of FIGS. 3G-3K.

FIG. 4 is a schematic elevational cross section through a hub adapterhaving a drive magnet separated from an interventional device hub anddriven magnet by a sterile barrier.

FIGS. 5A and 5B schematically illustrate a three interventional deviceand a four interventional device assembly.

FIG. 6 is a perspective view of a support table.

FIG. 7 is a close-up view of the motor drive end of a support table.

FIG. 8 is an elevational cross section through a motor and belt driveassembly.

FIG. 9 is a close-up view of a pulley end of the support table.

FIG. 10 is an elevational cross section through a belt pully.

FIG. 11 is a side elevational cross-section through a distal portion ofa catheter such as any of those shown in FIGS. 5A and 5B.

FIGS. 12A and 12B schematically illustrate a force sensor integratedinto the sidewall of the catheter.

FIGS. 13A and 13B schematically illustrate a sensor for measuringelastic forces at the magnetic coupling between the hub andcorresponding carriage.

FIG. 14 schematically illustrates a dual encoder torque sensor for usewith a catheter of the present disclosure.

FIG. 15 illustrates a clot capture and visualization device that can beintegrated into a hub and/or connected to an aspiration line.

FIGS. 16A-16C illustrate an example control mechanism for manipulatinginterventional devices driven by respective hubs.

FIG. 17 illustrates a side elevational schematic view of aninterventional device assembly for supra-aortic access andneuro-interventional procedures.

FIGS. 18A-18E depict an example sequence of steps of introducing acatheter assembly configured to achieve supra-aortic access andneurovascular site access.

FIG. 19 schematically illustrates an embodiment of a mechanical couplingbetween a drive mechanism and a driven mechanism.

FIGS. 20A-20C depict an example sequence of steps of priming a catheterassembly in a stacked configuration.

FIGS. 21A-21B depict an example sequence of steps of priming a catheterassembly in a stacked configuration.

FIG. 22 depicts an example test system for the priming process depictedin FIGS. 21A-21B.

FIG. 23A depicts an example of a catheter assembly.

FIG. 23B depicts an example of a catheter assembly after a primingprocedure.

FIG. 23C depicts an example of a catheter assembly after a primingprocedure including relative movement between adjacent catheters.

DETAILED DESCRIPTION

In certain embodiments, a system is provided for advancing a guidecatheter from a femoral artery or radial artery access into the ostiumof one of the great vessels at the top of the aortic arch, therebyachieving supra-aortic access. A surgeon can then take over and advanceinterventional devices into the cerebral vasculature via the roboticallyplaced guide catheter.

In some implementations, the system may additionally be configured torobotically gain intra-cranial vascular access and to perform anaspiration thrombectomy or other neuro vascular procedure.

A drive table is positioned over or alongside the patient, andconfigured to axially advance, retract, and in some cases rotate and/orlaterally deflect two or three or more different (e.g., concentricallyor side by side oriented) intravascular devices. The hub is moveablealong a path along the surface of the drive table to advance or retractthe interventional device as desired. Each hub may also containmechanisms to rotate or deflect the device as desired, and is connectedto fluid delivery tubes (not shown) of the type conventionally attachedto a catheter hub. Each hub can be in electrical communication with anelectronic control system, either via hard wired connection, RF wirelessconnection or a combination of both.

Each hub is independently movable across the surface of a sterile fieldbarrier membrane carried by the drive table. Each hub is releasablymagnetically coupled to a unique drive carriage on the table side of thesterile field barrier. The drive system independently moves each hub ina proximal or distal direction across the surface of the barrier, tomove the corresponding interventional device approximately or distallywithin the patient's vasculature.

The carriages on the drive table, which magnetically couple with thehubs to provide linear motion actuation, are universal. Functionality ofthe catheters/guidewire are provided based on what is contained in thehub and the shaft designs. This allows flexibility to configure thesystem to do a wide range of procedures using a wide variety ofinterventional devices on the same drive table. Additionally, theinterventional devices and methods disclosed herein can be readilyadapted for use with any of a wide variety of other drive systems (e.g.,any of a wide variety of robotic surgery drive systems).

FIG. 1 is a schematic perspective view of an interventional setup 10having a patient support table 12 for supporting a patient 14. Animaging system 16 may be provided, along with a robotic interventionaldevice drive system 18 in accordance with the present disclosure.

The drive system 18 may include a support table 20 for supporting, forexample, a guidewire hub 26, an access catheter hub 28 and a guidecatheter hub 30. In the present context, the term ‘access’ catheter canbe any catheter having a lumen with at least one distally facing orlaterally facing distal opening, that may be utilized to aspiratethrombus, provide access for an additional device to be advancedtherethrough or therealong, or to inject saline or contrast media ortherapeutic agents.

More or fewer interventional device hubs may be provided depending uponthe desired clinical procedure. For example, in certain embodiments, adiagnostic angiogram procedure may be performed using only a guidewirehub 26 and an access catheter hub 28 for driving a guidewire and anaccess catheter (in the form of a diagnostic angiographic catheter),respectively. Multiple interventional devices 22 extend between thesupport table 20 and (in the illustrated example) a femoral access point24 on the patient 14. Depending upon the desired procedure, access maybe achieved by percutaneous or cut down access to any of a variety ofarteries or veins, such as the femoral artery or radial artery. Althoughdisclosed herein primarily in the context of neuro vascular access andprocedures, the robotic drive system and associated interventionaldevices can readily be configured for use in a wide variety ofadditional medical interventions, in the peripheral and coronaryarterial and venous vasculature, gastrointestinal system, lymphaticsystem, cerebral spinal fluid lumens or spaces (such as the spinalcanal, ventricles, and subarachnoid space), pulmonary airways, treatmentsites reached via trans ureteral or urethral or fallopian tubenavigation, or other hollow organs or structures in the body (forexample, in intra-cardiac or structural heart applications, such asvalve repair or replacement, or in any endoluminal procedures).

A display 23 such as for viewing fluoroscopic images, catheter data(e.g., fiber Bragg grating fiber optics sensor data or other force orshape sensing data) or other patient data may be carried by the supporttable 20 and or patient support 12. Alternatively, the physicianinput/output interface including display 23 may be remote from thepatient, such as behind. radiation shielding, in a different room fromthe patient, or in a different facility than the patient.

In the illustrated example, a guidewire hub 26 is carried by the supporttable 20 and is moveable along the table to advance a guidewire into andout of the patient 14. An access catheter hub 28 is also carried by thesupport table 20 and is movable along the table to advance the accesscatheter into and out of the patient 14. The access catheter hub mayalso be configured to rotate the access catheter in response tomanipulation of a rotation control, and may also be configured tolaterally deflect a deflectable portion of the access catheter, inresponse to manipulation of a deflection control.

FIG. 2 is a longitudinal cross section schematically showing the motionrelationship between a guidewire 27 having two degrees of freedom (axialand rotation), an access catheter 29 having three degrees of freedom(axial, rotational and lateral deflection) and a guide catheter 31,having one degree of freedom (axial).

Referring to FIG. 3A, the support table 20 includes a drive mechanismdescribed in greater detail below, to independently drive the guidewirehub 26, access catheter hub 28, and guide catheter hub 30. Ananti-buckling feature 34 may be provided in a proximal anti-bucklingzone for resisting buckling of the portion of the interventional devicesspanning the distance between the support table 20 and the femoralartery access point 24. The anti-buckling feature 34 may comprise aplurality of concentric telescopically axially extendable andcollapsible tubes through which the interventional devices extend.

Alternatively, a proximal segment of one or more of the device shaftsmay be configured with enhanced stiffness to reduce buckling undercompression. For example, a proximal reinforced segment may extenddistally from the hub through a distance of at least about 5 centimetersor 10 centimeters but typically no more than about 120 centimeters or100 centimeters to support the device between the hub and the accesspoint 24 on the patient. Reinforcement may be accomplished by usingmetal or polymer tubing or embedding at least one or two or more axiallyextending elements into the wall of the device shafts, such as elongatewires or ribbons. In some implementations, the extending element may behollow and protect from abrasion, buckling, or damage at the inputs andoutputs of the hubs. In some embodiments, the hollow extending elementmay be a hollow and flexible coating attached to a hub. The hollow,extending element (e.g., a hollow and flexible coating) may cover aportion of the device shaft when threaded through the hubs. In someembodiments in which the hollow extending element is a coating, thecoating may be attached to a portion of a hub such that threading thecatheter device through the hub 26, 28, or 30 threads the catheterdevice through the coating as well. In some implementations, ananti-buckling device may be installed on or about or surrounding adevice shaft to avoid misalignment or insertion angle errors betweenhubs or between a hub and an insertion point. The anti-buckling devicemay be a laser cut hypotube, a spring, telescoping tubes, tensionedsplit tubing, or the like.

In some implementations, a number of deflection sensors may be placedalong a catheter length to identify buckling. Identifying buckling maybe performed by sensing that a hub is advancing distally, while thedistal tip of the catheter or interventional device has not moved. Insome implementations, the buckling may be detected by sensing that anenergy load (e.g., due to friction) has occurred between cathetershafts.

Alternatively, thin tubular stiffening structures can be embedded withinor carried over the outside of the device wall, such as a tubularpolymeric extrusion or length of hypo-tube. Alternatively, a removablestiffening mandrel may be placed within a lumen in the proximal segmentof the device, and proximally removed following distal advance of thehub towards the patient access site, to prevent buckling of the proximalshafts during distal advance of the hub. Alternatively, a proximalsegment of one or more of the device shafts may be constructed as atubular hypo tube, which may be machined (e.g., with a laser) so thatits mechanical properties vary along its length. This proximal segmentmay be formed of stainless steel, nitinol, and/or cobalt chrome alloys,optionally in combination with polymer components which may provide forlubricity and hydraulic sealing. In some embodiments, this proximalsegment may be formed of a polymer, such as polyether ether ketone(PEEK). Alternatively, the wall thickness or diameter of theinterventional device can be increased in the anti-buckling zone.

In certain embodiments, a device shaft having advanced stiffness (e.g.,axially and torsionally) may provide improved transmission of motionfrom the proximal end of the device shaft to the distal end of thedevice shaft. For example, the device shafts may be more responsive tomotion applied at the proximal end. Such embodiments may be advantageousfor robotic driving in the absence of haptic feedback to a user.

In some embodiments, a flexible coating can be applied to a device shaftand/or hub to reduce frictional forces between the device shaft and/orhub and a second device shaft when the second device shaft passestherethrough.

The interventional device hubs may be separated from the support table20 by sterile barrier 32. Sterile barrier 32 may comprise a thin plasticmembrane such as polyethylene terephthalate (PET), polyethyleneterephthalate glycol (PETG), polyethylene terephthalate (PETE),high-density polyethylene (HDPE), polyvinyl chloride (PVC), low-densitypolyethylene (LDPE), polypropylene (PP), polystyrene (PS), or styrene.This allows the support table 20 and associated drive system to resideon a non-sterile (lower) side of sterile barrier 32. The guidewire hub26, access catheter hub 28, guide catheter hub 30 and the associatedinterventional devices are all on a sterile (top) side of the sterilebarrier 32. The sterile barrier is preferably waterproof and can alsoserve as a tray used in the packaging of the interventional devices,discussed further below. The interventional devices can be providedindividually or as a coaxially preassembled kit that is shipped andstored in the tray and enclosed within a sterile packaging.

FIGS. 3B-3F schematically illustrate an alternate sterile barrier in theform of a dual function sterile barrier for placement on the supporttable during the interventional procedure, and shipping tray, having oneor more storage channels for carrying sterile interventional devices.The sterile barrier may also act as a sterile work surface forpreparation of catheters or other devices during a procedure.

Referring to FIGS. 3B and 3C, there is illustrated a sterile barrier 32in the form of a pre-shaped tray, for fitting over an elongate supporttable 20. In use, the elongate support table 20 would be positionedbelow the sterile barrier 32. The sterile barrier 32 extends between aproximal end 100 and a distal end 102 and includes an upper supportsurface 104 for supporting the interventional device hubs. In oneimplementation, the support surface 104 has an axial length greater thanthe length of the intended interventional devices, in a linear driveconfiguration.

The length of support surface 104 will typically be at least about 100centimeters and within the range of from about 100 centimeters to about2.7 meters. Shorter lengths may be utilized in a system configured toadvance the drive couplers along an arcuate path. In some embodiments,two or more support surfaces may be used instead of a single supportsurface 104. The two or more support surfaces may have a combined lengthbetween 100 centimeters to about 2.7 meters. The width of the lineardrive table is preferably no more than about 30 to 80 centimeters.

At least a first channel 106 may be provided, extending axially at leasta portion of the length of the support table 20. In the illustratedimplementation, first channel 106 extends the entire length of thesupport table 20. Preferably, the first channel 106 has a sufficientlength to hold the interventional devices, and sufficient width anddepth to hold the corresponding hubs (for example, by providing lateralsupport to prevent dislodgment of the hubs when forces are applied tothe hubs). First channel 106 is defined within a floor 108, outer sidewall 110 and inner side wall 111, forming an upwardly facing concavity.Optionally, a second channel 112 may be provided. Second channel 112 maybe located on the same side or the opposite side of the upper supportsurface 104 from the first channel 106. Two or three or more additionalrecesses such as additional channels or wells may be provided, to holdadditional medical devices or supplies that may be useful during theinterventional procedure as well as to collect fluids and function aswash basins for catheters and related devices.

Referring to FIG. 3D, the guide catheter hub 30 is shown positioned onthe upper support surface 104, and magnetically coupled to thecorresponding coupler holding the drive magnets, positioned beneath thesterile barrier 32. The access catheter hub 28 and access catheter 29,and guidewire hub 26 and guidewire 27 are illustrated residing withinthe first channel 106 such as before introduction through the guidecatheter 31 or following removal from the guide catheter 31.

The interventional devices may be positioned within the channel 106 andenclosed in a sterile barrier for shipping. At the clinical site, anupper panel of the sterile barrier may be removed, or a tubular sterilebarrier packaging may be opened and axially removed from the supporttable 20 and sterile barrier 32 assembly, exposing the sterile top sideof the sterile barrier tray and any included interventional devices. Theinterventional devices may be separately carried in the channel, orpreassembled into an access assembly or procedure assembly, discussed inadditional detail below.

FIGS. 3D-3F illustrate the support table with sterile barrier in place,and in FIG. 3E, the interventional devices configured in an accessassembly for aortic access, following coupling of the access assembly tothe corresponding carriages beneath the sterile barrier. The accessassembly may be preassembled with the guidewire fully advanced throughthe access catheter which is in turn fully advanced through the guidecatheter. In embodiments in which the access catheter or other cathetersare pre-shaped (i.e., pre-curved or not straight), the guidewire and/orouter catheters may be positioned so that relatively stiff sections arenot superimposed with curved stiffer sections of the pre-shapedcatheter, for example, to avoid creep or straightening of the pre-shapedcatheter and/or introduction of a curve into an otherwise straightcatheter. This access assembly may be lifted out of the channel 106 andpositioned on the support surface 104 for coupling to the respectivedrive magnets and introduction into the patient. The guide catheter hub30 is the distal most hub. Access catheter hub 28 is positionedproximally of the guide catheter hub, so that the access catheter 29 canextend distally through the guide catheter. The guidewire hub 26 ispositioned most proximally, in order to allow the guidewire 27 toadvance through the access catheter 29 and guide catheter 31.

A procedure assembly is illustrated in FIG. 3F following introduction ofthe procedure assembly through the guide catheter 31 that was used toachieve supra-aortic access. In this implementation, guide catheter 31remains the distal most of the interventional devices. A first procedurecatheter 120 and corresponding hub 122 is illustrated extending throughthe guide catheter 31. An optional second procedure catheter 124 andcorresponding hub 126 is illustrated extending through the firstprocedure catheter 120. The guidewire 27 extends through at least aportion of the second procedure catheter 124 in a rapid exchange versionof second procedure catheter 124, or the entire length of secondprocedure catheter 124 in an over the wire implementation.

As is discussed in greater detail in connection with FIG. 17 , the multicatheter stack may be utilized to achieve both access and theintravascular procedure without the need for catheter exchange. this maybe accomplished in either a manual or a robotically driven procedure. Inone example, the guide catheter 31 may comprise a catheter having aninner diameter of at least about 0.08 inches and in one implementationabout 0.088 inches. The first procedure catheter 120 may comprise acatheter having an inner diameter within the range of from about 0.065inches to about 0.075 inches and in one implementation catheter 120 hasan inner diameter of about 0.071 inches. The second procedure catheter124 may be an access catheter having an OD sized to permit advancethrough the first procedure catheter 120. The second procedure cathetermaybe steerable, having a deflection control 2908 configured tolaterally deflect a distal end of the catheter. The second procedure(access) catheter may also have an inner lumen sized to allow anappropriately sized guidewire to remain inside the second procedurecatheter while performing contrast injections through the secondprocedure catheter.

In certain embodiments, the catheter 31 may be a ‘large bore’ accesscatheter or guide catheter having a diameter of at least about 0.075 orat least about 0.080 inches in diameter. The catheter 120 may be anaspiration catheter having a diameter within the range of from about0.060 to about 0.075 inches. The catheter 124 may be a steerablecatheter with a deflectable distal tip, having a diameter within therange of from about 0.025 to about 0.050 inches. The guidewire 27 mayhave a diameter within the range of from about 0.014 to about 0.020inches. In one example, the catheter 31 may have a diameter of about0.088 inches, the catheter 120 about 0.071 inches, the catheter 124about 0.035 inches, and the guidewire 27 may have a diameter of about0.018 inches.

In one commercial execution, a preassembled access assembly (guidecatheter, access catheter and guidewire) may be carried within a firstchannel on the sterile barrier tray and a preassembled procedureassembly (one or two procedure catheters and a guidewire) may be carriedwithin the same or a different, second channel on the sterile barriertray. One or two or more additional catheters or interventional toolsmay also be provided, depending upon potential needs during theinterventional procedure.

FIGS. 3G-3K illustrate embodiments of an alternate sterile barrierhaving a convex drive surface (e.g., a convex, crowned road like drivesurface). FIG. 3G is a cross-sectional view of a sterile barrier 232.The sterile barrier 232 includes a convex upper support surface 204.Fluid channels 205 and 207 are positioned laterally of and below thesupport surface 204 for self-clearing or draining of fluids from thesupport surface 204 (for example, during an interventional procedure).The fluid channels 205 and 207 may extend axially at least a portion ofthe length of the sterile barrier.

FIGS. 3I, 3J, and 3K illustrate a sectional perspective view, across-sectional view, and a top sectional view, respectively, of aproximal end of the sterile barrier 232. As shown, in FIGS. 3I-3K, thesterile barrier 232 can include a trough 240 in communication with thefluid channels 205 and 207. The trough 240 can receive fluids from thechannels 205 and 207 (for example, during an interventional procedure).The trough 240 may be positioned at least partially below the fluidchannels 205 and 207 so that fluid within the channels 205 and 207 flowsinto the trough 240. In certain embodiments, the fluid channels 205 and207 may be angled relative to a horizontal plane (for example, maydecline from an end of the channel furthest from the trough 240 to thetrough 240) so that fluid within the channels 205 and 207 is directed tothe trough 240. For example, the channels 205 and 207 may increase indepth from an end of the channels furthest from the trough 240 to thetrough 240. Alternatively, the sterile barrier 232 and/or support tablemay be positioned at an angle relative to a horizontal plane, duringpart of or an entirety of an interventional procedure, such that the endof the channels 205 and 207 furthest from the trough 240 is positionedhigher than the trough 240. For example, the sterile barrier 232 and/orsupport table may be constructed or arranged in an angled arrangement sothat an end of the sterile barrier 232 and/or support table opposite thetrough 240 is positioned higher than the trough 240. Alternatively oradditionally, a drive mechanism may temporarily tilt the sterile barrier232 and/or support table so that an end of the sterile barrier 232and/or support table opposite the trough 240 is positioned higher thanthe trough 240 (for example, by lifting an end of the sterile barrierand/or support table opposite the trough 240 or lowering an end of thesterile barrier 232 and/or support table at which the trough 240 ispositioned) so that fluids within the channels 205 and 207 flow into thetrough 240.

The trough 240 can include a drain hole 242. The trough 240 can beshaped, dimensioned, and/or otherwise configured so that fluid withinthe trough 240 empties to the drain hole 242. The drain hole 242 caninclude tubing, a barb fitting, and/or an on-off valve for removal offluids from the trough 240. As shown in FIGS. 3I-3K, the trough 240 canbe positioned at the proximal end of the sterile barrier 232. Inalternate embodiments, the trough 240 may be positioned at a distal endof the sterile barrier 232. In some embodiments, the sterile barrier 232can include a first trough 240 at the proximal end and a second trough240 at the distal end. In some embodiments, the trough 240 can also beused as a wash basin.

A first channel 206 may extend axially at least a portion of the lengthof the sterile barrier 232. The channel 206 can have a sufficient lengthto hold the interventional devices, and sufficient width and depth tohold the corresponding hubs (for example, by providing support toprevent dislodgement of the hubs when forces are applied to the hubs).Optionally, a second channel 212 may be provided. The second channel 212may be located on the same side or the opposite side of the uppersupport surface 204 from the first channel 206. FIG. 3G illustrates thechannel 212 located on the opposite side of the support surface 204 fromthe channel 206. FIG. 3H is a cross-sectional view illustrating analternate embodiment of the sterile barrier 232 in which the channel 212is on the same side of the support surface 204 as the channel 206.

As shown in FIGS. 3G and 3H, the channels 206 and 212 can have generallytriangular, wedge-shaped, or otherwise angled cross-sections, so as tohold the hubs at an angle relative to a horizontal plane. Holding thehubs at an angle relative to the horizontal plane can allow for smallerwidth of the sterile barrier 232.

Two or three or more additional recesses such as additional channels orwells may be provided, to hold additional medical devices or suppliesthat may be useful during the interventional procedure as well as tocollect fluids and function as wash basins for catheters and relateddevices.

In some embodiments, the sterile barrier 232 can include one or morestructural ribs 236. The sterile barrier 232 can further include one ormore frame support bosses 228 and 238.

In the embodiment of the sterile barrier 232 shown in FIG. 3G, a widthx₁ can be 14 in, about 14 in, between 12 in and 16 in, between 10 in and18 in, or any other suitable width. In the embodiment of the sterilebarrier 232 shown in FIG. 3H, the width x₁ can be in, about 15 in,between 13 in and 17 in, between 11 in and 19 in, or any other suitablewidth. A height y₁ of the support surface 204 can be 0.125 in, about0.125 in, between 0.1 and in, or any other suitable height. In someembodiments, the support surface 204 can be recessed from a top surface233 of the sterile barrier 232. A height y₂ between a bottom of thesupport surface 204 and the top surface 233 can be 0.5 in, about 0.5 in,between 0.25 in and in, or any other suitable height. A width x₂ from alateral edge of the channel 205 to a lateral edge of the channel 207 canbe 5 in, about 5 in, between 4 in and 6 in, or any other suitable width.A width x₃ of the support surface 204 can be 4 in, about 4 in, between 3in and in, or any other suitable width. A height y₃ of the channel 206and/or channel 212 can be 1.5 in, about 1.5 in, between 1 in and 2 in,or any other suitable height. A width x₄ of the channel 206 and/orchannel 212 can be 3 in, about 3 in, between 2 in and 4 in, or any othersuitable width. The channel 206 and/or channel 212 can be defined by anarc angle α of 90°, about 90°, between 80° and 100°, or any othersuitable angle, and a radius of curvature of 0.125 in, about in, between0.1 and 0.15 in, or any other suitable radius of curvature. In certainembodiments, an arc angle α of 90° or about 90° may be used to hold ahub having a rectangular or generally rectangular cross-section. Thesupport surface 204 can be defined by a radius of curvature of 13 in,about 13 in, between 11 in and 15 in, or any other suitable radius ofcurvature. The channel 205 and/or channel 207 can be defined by a radiusof curvature of 0.25 in, about 0.25 in, between 0.15 in and 0.35 in, orany other suitable radius of curvature.

FIGS. 3L and 3M depict example dimensions of a hub 250 that may be usedwith the sterile barrier 232 as shown in FIGS. 3G-3K. The hub 250 may beany of the hubs described herein. In certain embodiments, the hub 250can have a width w₁ of 3.75 in, about 3.75 in, between 3.25 in and 4.25in, or any other suitable width. The hub 250 can have a height h1 of 1.5in, about 1.5 in, between 1.25 in and 1.75 in, or any other suitableheight. Alternatively, the hub 250 can have a height h₂ of 2 in, about 2in, between 1.75 in and 2.25 in, or any other suitable height. In someembodiments, the hub 250 can have a length L₁ of 2.5 in, about 2.5 in,between 2 in and 3 in or any other suitable length. Alternatively, thehub 250 can have a length L₂ of 4 in, about 4 in, between 3.25 in and4.75 in, or any other suitable length.

In some embodiments, a top surface of the support table can includesurface features that generally correspond to those of the sterilebarrier 232. For example, the support table can include a convex surfaceconfigured to correspond to the shape, size, and location of the supportsurface 204 and/or one or more recesses configured to correspond to theshape, size, and location of the channels 205 and 207.

In alternate embodiments, a planar support surface (for example, supportsurface 104 of sterile barrier 32) can be positioned at an angle to ahorizontal plane to facilitate the draining of fluids. In someembodiments, the sterile barrier and/or support table may be positioned,during part of or the entirety of an interventional procedure, at anangle to a horizontal plane to facilitate the draining of fluids. Forexample, the sterile barrier and/or support table may be constructed orarranged in an angled arrangement (for example, so that one lateral sideof the planar support surface is positioned higher than the otherlateral side of the planar support surface, the proximal end is higherthan the distal end, or the distal end is higher than the proximal end)to facilitate the drainage of fluids. Alternatively or additionally, adrive mechanism may temporarily tilt the sterile barrier and/or supporttable (for example, so that one lateral side of the planar supportsurface is positioned higher than the other lateral side of the planarsupport surface, the proximal end is higher than the distal end, or thedistal end is higher than the proximal end) to facilitate the drainageof fluids. For example, the drive mechanism may raise or lower onelateral side of the sterile barrier and/or support table, the proximalend of the sterile barrier and/or support table, and/or the distal endof the sterile barrier and/or support table.

In certain embodiments, a support surface (for example, support surface104 of sterile barrier 32) can be positioned in a vertical configurationinstead in the horizontal configuration shown, for example, in FIGS.3A-3F. For example, the support surface 104 can be positioned at about90 degrees (or any other suitable angle) from a horizontal plane (e.g.,rotated 90 degrees about a long axis of the support surface 104 relativeto the embodiment shown in of FIGS. 3A-3F). A vertical configuration mayprovide for easier interaction with the drive system 18 by a physician,A vertical configuration may also provide for a lower axis of cathetertravel closer to a patient without adding standoff height to the drivesystem 18.

In some embodiments, the drive system 18 may be positioned, during partof or the entirety of an interventional procedure, at an angle to ahorizontal plane to facilitate the draining of fluids. For example, thedrive system 18 may be constructed or arranged in an angled arrangement(for example, so that one lateral side of the planar support surface ispositioned higher than the other lateral side of the planar supportsurface, the proximal end is higher than the distal end, or the distalend is higher than the proximal end) to facilitate the drainage offluids. Alternatively or additionally, a drive mechanism may temporarilytilt the drive system 18 (for example, so that one lateral side of thedrive system 18 is positioned higher than the other lateral side of thedrive system 18, the proximal end is higher than the distal end, or thedistal end is higher than the proximal end) to facilitate the drainageof fluids. For example, the drive mechanism may raise or lower onelateral side of the system 18, the proximal end of the drive system 18,and/or the distal end of the drive system 18. In some embodiments, thedrive system 18 may be angled so that it extends at an angle away fromaxis point 24 (for example, so that the proximal end is higher than thedistal end), for example, to allow for clearance of a patient's feet.

Referring to FIG. 4 , hub 36 may represent any of the hubs previouslydescribed. Hub 36 includes a housing 38 which extends between a proximalend 40 and a distal end 42. An interventional device 44, which could beany of the interventional devices disclosed herein, extends distallyfrom the hub 36 and into the patient 14 (not illustrated). A hub adapter48 or carriage acts as a shuttle by advancing proximally or distallyalong a track in response to operator instructions or controllermanipulations. The hub adapter 48 includes at least one drive magnet 67configured to couple with a driven magnet 69 carried by the hub 36. Thisprovides a magnetic coupling between the drive magnet 67 and drivenmagnet 69 through the sterile barrier such that the hub 36 is movedacross the top of the sterile barrier 32 in response to movement of thehub adapter 48 outside of the sterile field. Movement of the hub adapteris driven by a drive system carried by the support table and describedin additional detail below.

To reduce friction in the system, the hub 36 may be provided with atleast a first roller 53 and a second roller 55 which may be in the formof wheels or rotatable balls or drums. The rollers space the sterilebarrier apart from the surface of the driven magnet 69 by at least about0.02 centimeters (about 0.008 inches) and generally no more than about0.08 centimeters (about 0.03 inches). In some implementations, the spaceis within the range of from about 0.03 centimeters (about 0.010 inches)and about 0.041 centimeters (about 0.016 inches). The space between thedrive magnet 67 and driven magnet 69 is generally no more than about0.38 centimeters (about 0.15 inches) and in some implementations is nomore than about 0.254 centimeters (about 0.10 inches) such as within therange of from about 0.216 centimeters (about 0.085 inches) to about0.229 centimeters (about 0.090 inches). The hub adapter 48 may similarlybe provided with at least a first hub adapter roller 59 and the secondhub adapter roller 63, which may be positioned opposite the respectivefirst roller 53 and second roller 55 as illustrated in FIG. 4 .

Referring to FIG. 6 , there is schematically illustrated one example ofa low-profile linear drive support table 20. Support table 20 comprisesan elongated frame 51 extending between a proximal end 52 and a distalend 54. At least one support table support 56 is provided to stabilizethe support table 20 with respect to the patient (not illustrated).Support 56 may comprise one or more legs or preferably an articulatingarm configured to allow movement and positioning of the frame 51 over oradjacent to the patient.

One example of a linear drive table 20 illustrated in FIG. 7 includesthree distinct drives. However, two drives or four or more drives (e.g.,up to eight drives) may be included depending upon the desired clinicalperformance. A first drive pulley 58 engages a first drive belt 60. Afirst carriage bracket 61 is secured to the first drive belt 60 suchthat rotation of the first drive pulley 58 causes rotation of the firstdrive belt 60 through an elongate closed loop path. The first carriagebracket 61 may be advanced in a proximal or distal direction along thelongitudinal axis of the support table 20 depending upon the directionof rotation of the drive pully 58. In the illustrated implementation,the drive pulley 58 is provided with surface structures such as aplurality of drive pulley teeth 62 for engaging complementary teeth onthe first drive belt 60.

A second drive pulley 64 may engage a second drive belt 66 configured toaxially move a second carriage bracket 68 along an axial path on thesupport table 20. A third drive pulley 70 may be configured to drive athird drive belt 72, to advance a third carriage bracket 73 axiallyalong the support table 20. Each of the carriage brackets may beprovided with a drive magnet assembly discussed previously but notillustrated in FIG. 7 , to form couplers for magnetically coupling to acorresponding driven magnet within the hub of an interventional deviceas has been discussed.

A detailed view of a drive system is shown schematically in FIG. 8 . Adrive support 74 may be carried by the frame 51 for supporting the driveassembly. The second drive pulley 64 is shown in elevational crosssection as rotationally driven by a motor 75 via a rotatable shaft 76.The rotatable shaft 76 may be rotatably carried by the support 74 via afirst bearing 78, a shaft coupling 80 and second bearing 79. Motor 75may be stabilized by a motor bracket 82 connected to the drive support74 and or the frame 51. The belt drive assemblies for the first drivebelt 60 and third drive belt 72 maybe similarly constructed and are notfurther detailed herein. In some embodiments, the drive systemsdescribed herein may be a rack and pinion drive table system that isfoldable. In such embodiments, motors 75 may be attached to and movewith the carriages.

Referring to FIGS. 9 and 10 , each of the first second and third drivebelts extends around a corresponding first idler pulley 84 second idlerpulley 86 and third idler pulley 88. Each idler pulley may be providedwith a corresponding tensioning bracket 90, configured to adjust theidler pulleys in a proximal or distal direction in order to adjust thetension of the respective belt. Each tensioning bracket 90 is thereforeprovided with a tensioning adjustment 92 such as a rotatable screw.

As seen in FIG. 10 , the second idler pulley 86, for example, may becarried by a rotatable shaft 94, rotatably secured with respect to themounting bracket by a first bearing 96 and second bearing 98.

Any of the catheters illustrated, for example, in FIGS. 5A, 5B or 11generally comprise an elongate tubular body extending between a proximalend and a distal functional end. The length and diameter of the tubularbody depends upon the desired application. For example, lengths in thearea of from about 90 centimeters to about 195 centimeters or more aretypical for use in femoral access percutaneous transluminal coronaryapplications. Intracranial or other applications may call for adifferent catheter shaft length depending upon the vascular access site.

Any of the catheters disclosed herein may be provided with an inclineddistal tip. Referring to FIG. 11 , distal catheter tip 1150 comprises atubular body 1152 which includes an advance segment 1154, a marker band1156 and a proximal segment 1158. An inner tubular liner 1160 may extendthroughout the length of the distal catheter tip 1150, and may comprisedip coated or extruded PTFE or other lubricious material.

A reinforcing element 1162 such as a braid and/or spring coil isembedded in an outer jacket 1164 which may extend the entire length ofthe catheter.

The advance segment 1154 terminates distally in an angled face 1166, toprovide a leading side wall portion 1168 having a length measuredbetween the distal end 130 of the marker band 1156 and a distal tip1172. In some embodiments, the entire distal tip may be shaped to avoidsnagging the tip in areas of arterial bifurcation. A trailing side wallportion 1174 of the advance segment 1154, has an axial length in theillustrated embodiment of approximately equal to the axial length of theleading side wall portion 1168 as measured at approximately 180 degreesaround the catheter from the leading side wall portion 1168. The leadingside wall portion 1168 may have an axial length within the range of fromabout 0.1 millimeters to about 5 millimeters and generally within therange of from about 1 to 3 millimeters. The trailing side wall portion1174 may be equal to or at least about 0.1 or 0.5 or 1 millimeter or 2millimeters or more shorter than the axial length of the leading sidewall portion 1168, depending upon the desired performance.

The angled face 1166 inclines at an angle A within the range of fromabout 45 degrees to about 80 degrees from the longitudinal axis of thecatheter. For certain implementations, the angle is within the range offrom about 55 degrees to about 65 degrees from the longitudinal axis ofthe catheter. In one implementation, the angle A is about 60 degrees.One consequence of an angle A of less than 90 degrees is an elongationof a major axis of the area of the distal port which increases thesurface area of the port and may enhance clot aspiration or retention.Compared to the surface area of the circular port (angle A is 90degrees), the area of the angled port is generally at least about 105percent, and no more than about 130 percent, in some implementationswithin the range of from about 110 percent and about 125 percent, and inone example is about 115 percent of the area of the correspondingcircular port (angle A is 90 degrees).

In the illustrated embodiment, the axial length of the advance segmentis substantially constant around the circumference of the catheter, sothat the angled face 1166 is approximately parallel to the distalsurface 1176 of the marker band 1156. The marker band 1156 has aproximal surface approximately transverse to the longitudinal axis ofthe catheter, producing a marker band 1156 having a right trapezoidconfiguration inside elevational view. A short sidewall 1178 isrotationally aligned with the trailing side wall portion 1174, and hasan axial length within the range of from about 0.2 millimeters to about4 millimeters, and typically from about 0.5 millimeters to about 2millimeters. An opposing long sidewall 1180 is rotationally aligned withthe leading side wall portion 1168. Long sidewall 1180 of the markerband 1156 is generally at least about 10 percent or 20 percent longerthan short sidewall 1178 and may be at least about 50 percent or 70percent or 90 percent or more longer than short sidewall 1178, dependingupon desired performance. Generally, the long sidewall 1180 will have alength of at least about 0.5 millimeters or 1 millimeter and less thanabout 5 millimeters or 4 millimeters.

The marker band may be a continuous annular structure, or may have atleast one and optionally two or three or more axially extending slitsthroughout its length. The slit may be located on the short sidewall1178 or the long sidewall 1180 or in between, depending upon desiredbending characteristics. The marker band may comprise any of a varietyof radiopaque materials, such as a platinum/iridium alloy, with a wallthickness preferably no more than about 0.003 inches and in oneimplementation is about 0.001 inches.

The fluoroscopic appearance of the marker bands may be unique ordistinct for each catheter size or type when a plurality of catheters isutilized so that the marker bands can be distinguishable from oneanother by a software algorithm. Distinguishing the marker bands of aplurality of catheters may be advantageous when the multiple cathetersare used together, for example, in a multi catheter assembly or stack asdescribed herein. In some embodiments, the marker band of a catheter maybe configured so that a software algorithm can detect motion of thecatheter tip.

The marker band zone of the assembled catheter may have a relativelyhigh bending stiffness and high crush strength, such as at least about50 percent or at least about 100 percent less than proximal segment 18but generally no more than about 200 percent less than proximal segment1158. The high crush strength may provide radial support to the adjacentadvance segment 1154 and particularly to the leading side wall portion1168, to facilitate the functioning of distal tip 1172 as an atraumaticbumper during transluminal advance and to resist collapse under vacuum.The proximal segment 1158 preferably has a lower bending stiffness thanthe marker band zone, and the advance segment 1154 preferably has even alower bending stiffness and crush strength than the proximal segment1158.

The advance segment 1154 may comprise a distal extension of the outertubular jacket 1164 and optionally the inner liner 1160, without otherinternal supporting structures distally of the marker band 1156. Outerjacket 1164 may comprise extruded polyurethane, such as Tecothane®. Theadvance segment 1154 may have a bending stiffness and radial crushstiffness that is no more than about 50 percent, and in someimplementations no more than about 25 percent or 15 percent or 5 percentor less than the corresponding value for the proximal segment 1158.

The catheter may further comprise an axial tension element or supportsuch as a ribbon or one or more filaments or fibers for increasing thetension resistance and/or influencing the bending characteristics in thedistal zone. The tension support may comprise one or more axiallyextending mono strand or multi strand filaments. The one or more tensionelement 1182 may be axially placed inside the catheter wall near thedistal end of the catheter. The one or more tension element 1182 mayserve as a tension support and resist tip detachment or elongation ofthe catheter wall under tension (e.g., when the catheter is beingproximally retracted through a kinked outer catheter or tortuous ornarrowed vasculature).

At least one of the one or more tension element 1182 may proximallyextend along the length of the catheter wall from within about 1.0centimeters from the distal end of the catheter to less than about 10centimeters from the distal end of the catheter, less than about 20centimeters from the distal end of the catheter, less than about 30centimeters from the distal end of the catheter, less than about 40centimeters from the distal end of the catheter, or less than about 50centimeters from the distal end of the catheter.

The one or more tension element 1182 may have a length greater than orequal to about 40 centimeters, greater than or equal to about 30centimeters, greater than or equal to about 20 centimeters, greater thanor equal to about 10 centimeters, or greater than or equal to about 5centimeters.

At least one of the one or more tension element 1182 may extend at leastabout the most distal 50 centimeters of the length of the catheter, atleast about the most distal 40 centimeters of the length of thecatheter, at least about the most distal 30 centimeters or 20centimeters or 10 centimeters of the length of the catheter.

In some implementations, the tension element extends proximally from thedistal end of the catheter along the length of the coil 24 and endsproximally within about 5 centimeters or 2 centimeters or less eitherside of a transition between a distal coil and a proximal braid. Thetension element may end at the transition without overlapping with thebraid.

The one or more tension element 1182 may be placed near or radiallyoutside the inner liner 1160. The one or more tension element 1182 maybe placed near or radially inside the braid and/or the coil. The one ormore tension element 1182 may be carried between the inner liner 1160and the helical coil, and may be secured to the inner liner or otherunderlying surface by an adhesive prior to addition of the next outeradjacent layer such as the coil. Preferably, the tension element 1182 issecured to the marker band 1156 such as by adhesives or by mechanicalinterference. In one implementation, the tension element 1182 extendsdistally beyond the marker band on a first (e.g., inside) surface of themarker band, then wraps around the distal end of the marker band andextends along a second (e.g., outside) surface in either or both aproximal inclined or circumferential direction to wrap completely aroundthe marker band.

When more than one tension element 1182 or filament bundles are spacedcircumferentially apart in the catheter wall, the tension elements 1182may be placed in a radially symmetrical manner. For example, the anglebetween two tension elements 1182 with respect to the radial center ofthe catheter may be about 180 degrees. Alternatively, depending ondesired clinical performances (e.g., flexibility, trackability), thetension elements 1182 may be placed in a radially asymmetrical manner.The angle between any two tension elements 1182 with respect to theradial center of the catheter may be less than about 180 degrees, lessthan or equal to about 165 degrees, less than or equal to about 135degrees, less than or equal to about 120 degrees, less than or equal toabout 90 degrees, less than or equal to about 45 degrees or, less thanor equal to about 15 degrees.

The one or more tension element 1182 may comprise materials such asVectran®, Kevlar®, Polyester®, Spectra®, Dyneema®, Meta-Para-Aramide®,or any combinations thereof. At least one of the one or more tensionelement 1182 may comprise a single fiber or a multi-fiber bundle, andthe fiber or bundle may have a round or rectangular (e.g., ribbon) crosssection. The terms fiber or filament do not convey composition, and theymay comprise any of a variety of high tensile strength polymers, metalsor alloys depending upon design considerations such as the desiredtensile failure limit and wall thickness. The cross-sectional dimensionof the one or more tension element 1182, as measured in the radialdirection, may be no more than about 2 percent, 5 percent, 8 percent, 15percent, or 20 percent of that of the catheter 10.

The cross-sectional dimension of the one or more tension element 1182,as measured in the radial direction, may be no more than about 0.03millimeters (about 0.001 inches), no more than about 0.0508 millimeters(about 0.002 inches), no more than about 0.1 millimeters (about 0.004inches), no more than about 0.15 millimeters (about 0.006 inches), nomore than about 0.2 millimeters (about 0.008 inches), or about 0.38millimeters (about 0.015 inches).

The one or more tension element 1182 may increase the tensile strengthof the distal zone of the catheter before failure under tension (e.g.,marker band detachment) to at least about 1 pound, at least about 2pounds, at least about 3 pounds, at least about 4 pounds, at least about5 pounds, at least about 6 pounds, at least about 7 pounds, at leastabout 8 pounds, or at least about 10 pounds or more.

Any of a variety of sensors may be provided on any of the catheters,hubs, carriages, or table, depending upon the desired data. For example,in some implementations, it may be desirable to measure axial tension orcompression force applied to the catheter such as along a force sensingzone. The distal end of the catheter would be built with a similarconstruction as illustrated in FIG. 11 , with a helical coil distalsection. But instead of using a single helical coil of nitinol wire, afirst conductor 140 and second conductor 142 are wrapped intointertwined helical coils and electrically isolated from each other suchas by the plastic/resin of the tubular body. See FIG. 12A. Each coil isin electrical communication with the proximal hub by a unique electricalconductor such as a conductive trace or proximal extension of the wire.

This construction of double, electrically isolated helical coils createsa capacitor. This is roughly equivalent to two plates of nitinol with aplastic layer between them, illustrated in FIG. 12B. The capacitance isinversely proportional to the distance between wires. The only variablethat would be changing would be d, the distance between the plates. Ifan axial compressive force is applied to the catheter, the wires (e.g.,conductor 140 and conductor 142) will move closer together, thusincreasing the capacitance. If an axial tensile force is applied, thewires will get further apart, decreasing the capacitance. Thiscapacitance can be measured at the proximal end of the catheter, givinga measurement of the force at the helical capacitor. Although referredto as a capacitor, this sensor is measuring the electrical interactionbetween the two coils of wire. There may be a measurable change ininductance or other resulting change due to applied axial forces.

At least a first helical capacitor may have at least one or five or tenor more complete revolutions of each wire. A capacitor may be locatedwithin the distal most 5 or 10 or 20 centimeters of the catheter body tosense forces experienced at the distal end. At least a second capacitormay be provided within the proximal most 5 or 10 or 20 centimeters ofthe catheter body, to sense forces experienced at the proximal end ofthe catheter.

It may also be desirable to measure elastic forces across the magneticcoupling between the hub and corresponding carriage, using the naturalspringiness (compliance) of the magnetic coupling to measure the forceapplied to the hub. The magnetic coupling between the hubs and carriagescreates a spring. When a force is applied to the hub, the hub will movea small amount relative to the carriage. See FIG. 13A. In robotics, thisis called a series elastic actuator. This property can be used tomeasure the force applied from the carriage to the hub. To measure theforce, the relative distance between the hub and the carriage (dx shownin FIG. 13A) is determined and characterize some effective springconstant k between the two components. See FIG. 13B.

The relative distance could be measured in multiple different ways. Onemethod for measuring the relative distance between the puck and carriageis a magnetic sensor (e.g., a Hall effect Sensor between hub andcarriage). A magnet is mounted to either the hub or carriage, and acorresponding magnetic sensor is mounted on the other device (carriageor hub). The magnetic sensor might be a hall effect sensor, amagnetoresistive sensor, or another type of magnetic field sensor.Generally, multiple sensors may be used to increase the reliability ofthe measurement. This reduces noise and reduces interference fromexternal magnetic fields.

Other non-contact distance sensors can also be used. These includeoptical sensors, inductance sensors, and capacitance sensors. Opticalsensors would preferably be configured in a manner that avoidsaccumulation of blood or other fluid in the interface between the hubscarriages. In some implementations, wireless (i.e., inductive) power maybe used to translate movement and/or transfer information across thesterile barrier between a drive carriage and a hub, for example.

The magnetic coupling between the hub and the carriage has a shear oraxial break away threshold which may be about 300 grams or 1000 grams ormore. The processor can be configured to compare the axial force appliedto the catheter to a preset axial trigger force which if applied to thecatheter is perceived to create a risk to the patient. If the triggerforce is reached, the processor may be configured to generate a responsesuch as a visual, auditory or tactile feedback to the physician, and/orintervene and shut down further advance of the catheter until a reset isaccomplished. An override feature may be provided so the physician canelect to continue to advance the catheter at forces higher than thetrigger force, in a situation where the physician believes theincremental force is warranted.

Force and or torque sensing fiber optics (e.g., Fiber Bragg Grating(FBG) sensors) may be built into the catheter side wall to measure theforce and/or torque at various locations along the shaft of a catheteror alternatively may be integrated into a guidewire. The fiber measuresaxial strain, which can be converted into axial force or torque (whenwound helically). At least a first FBG sensor can be integrated into adistal sensing zone, proximal sensing zone and/or intermediate sensingzone on the catheter or guidewire, to measure force and or torque in thevicinity of the sensor.

It may also be desirable to understand the three-dimensionalconfiguration of the catheter or guidewire during and/or followingtransvascular placement. Shape sensing fiber optics such as an array ofFBG fibers to sense the shape of catheters and guidewires. By usingmultiple force sensing fibers that are a known distance from each other,the shape along the length of the catheter/guidewire can be determined.

A resistive strain gauge may be integrated into the body of the catheteror guidewire to measure force or torque. Such as at the distal tipand/or proximal end of the device.

Measurements of force and/or torque applied to the catheter or guidewireshafts can be used to determine applied force and/or torque above asafety threshold. When an applied force and/or torque exceeds a safetythreshold, a warning may be provided to a user. Applied force and/ortorque measurements may also be used to provide feedback related tobetter catheter manipulation and control. Applied force and/or torquemeasurements may also be used with processed fluoroscopic imaginginformation to determine or characterize distal tip motion.

Absolute position of the hubs (and corresponding catheters) along thelength of the table may be determined in a variety of ways. For example,a non-contact magnetic sensor may be configured to directly measure theposition of the hubs through the sterile barrier. The same type ofsensor can also be configured to measure the position of the carriages.Each hub may have at least one magnet attached to it. The robotic tablewould have a linear array of corresponding magnetic sensors going theentire length of the table. A processor can be configured to determinethe location of the magnet along the length of the linear sensor array,and display axial position information to the physician.

The foregoing may alternatively be accomplished using a non-contactinductive sensor to directly measure the position of the pucks throughthe sterile barrier. Each hub or carriage may be provided with aninductive “target” in it. The robotic table may be provided with aninductive sensing array over the entire working length of the table. Asa further alternative, an absolute linear encoder may be used todirectly measure the linear position of the hubs or carriages. Theencoder could use any of a variety of different technologies, includingoptical, magnetic, inductive, and capacitive methods.

In one implementation, a passive (no electrical connections) target coilmay be carried by each hub. A linear printed circuit board (PCB) may runthe entire working length of the table (e.g., at least about 1.5 metersto about 1.9 meters) configured to ping an interrogator signal whichstimulates a return signal from the passive coil. The PCB is configuredto identify the return signal and its location.

Axial position of the carriages may be determined using a multi-turnrotary encoder to measure the rotational position of the pulley, whichdirectly correlates to the linear position of the carriage. Directmeasurement of the location of the carriage may alternatively beaccomplished by recording the number of steps commanded to the steppermotor to measure the rotational position of the pulley, which directlycorrelates to the linear position of the carriage.

The location of the catheters and guidewires within the anatomy may alsobe determined by processing the fluoroscopic image with machine vision,such as to determine the distal tip position, distal tip orientation,and/or guidewire shape. Comparing distal tip position or movement orlack thereof to commanded or actual proximal catheter or guidewiremovement at the hub, may be used to detect a loss of relative motion,which may be indicative of a device shaft buckling, prolapse, kinking,or a similar outcome (for example, along the device shaft length insidethe body (e.g., in the aorta) or outside the body between hubs. Theprocessing may be done in real time to provide position/orientation dataat up to 30 Hertz, although this technique would only provide data whilethe fluoroscopic imaging is turned on. In some embodiments, machinevision algorithms can be used to generate and suggest optimal cathetermanipulations to access or reach anatomical landmarks, similar to driverassist. The machine vision algorithms may utilize data to automaticallydrive the catheters depending on the anatomy presented by fluoroscopy.

Proximal torque applied to the catheter or guidewire shaft may bedetermined using a dual encoder torque sensor. Referring to FIG. 14 , afirst encoder 144 and a second encoder 146 may be spaced axially apartalong the shaft 148, for measuring the difference in angle over a lengthof flexible catheter/tube. The difference in angle is interpolated as atorque, since the catheter/tube has a known torsional stiffness. Astorque is applied to the shaft, the slightly flexible portion of theshaft will twist. The difference between the angles measured by theencoders (dθ) tells us the torque. T=k*dθ, where k is the torsionalstiffness.

Confirming the absence of bubbles in fluid lines may also beaccomplished using bubble sensors, particularly where the physician isremote from the patient. This may be accomplished using a non-contactultrasonic sensor that measures the intensity and doppler shift of thereflected ultrasound through the sidewall of fluid tubing to detectbubbles and measure fluid flow rate or fluid level. An ultrasonic oroptical sensor may be positioned adjacent an incoming fluid flow pathwithin the hub, or in a supply line leading to the hub. To detect thepresence of air bubbles in the infusion line (that is formed ofultrasonically or optically transmissive material) the sensor mayinclude a signal source on a first side of the flow path and a receiveron a second side of the flow path to measure transmission through theliquid passing through the tube to detect bubbles. Alternatively, areflected ultrasound signal may be detected from the same side of theflow path as the source due to the relatively high echogenicity ofbubbles.

Preferably, a bubble removal system is automatically activated upondetection of in line bubbles. A processor may be configured to activatea valve positioned in the flow path downstream of the bubble detector,upon the detection of bubbles. The valve diverts a column of fluid outof the flow path to the patient and into a reservoir. Once bubbles areno longer detected in the flow path and after the volume of fluid in theflow path between the detector and the valve has passed through thevalve, the valve may be activated to reconnect the source of fluid withthe patient through the flow path. In other embodiments, the bubbleremoval system can include a pump and control system upstream of thebubble detector for removal of in line bubbles. A processor may beconfigured to activate the pump upon detection of bubbles to reverse thefluid flow and clear the bubbles into a waste reservoir beforereestablishing bubble free forward flow.

It may additionally be desirable for the physician to be able to viewaspirated clot at a location within the sterile field and preferably asclose to the patient as practical for fluid management purposes. Thismay be accomplished by providing a clot retrieval device mounted on thehub, or in an aspiration line leading away from the hub in the directionof the pump. Referring to FIG. 15 , one example of a clot retrievaldevice 370 can include a body 380 enclosing a chamber 381 whichcommunicates with a first port 310 and a second port 320.

In some embodiments, the body 380 includes a housing having a topportion 382 and a bottom portion 384. The body 380 may include a filter330 positioned in the chamber 381 between the top portion 382, and thebottom portion 384. In some examples, the first port 310 is configuredto connect to a first end of a first tube 340 that is fluidly connectedto a proximal end of an aspiration catheter.

In an embodiment that is configured to be connected downstream from thehub, the first tube 340 includes a connector 342 positioned at a secondend of the first tube 340 that is configured to engage or mate with acorresponding connector on or in communication with the hub. The firstport 310 directly communicates with the chamber on the upstream (e.g.,top side) of the filter, and the second port 320 directly communicateswith the chamber on the downstream (e.g., bottom side) of the filter tofacilitate direct visualization of material caught on the upstream sideof the filter.

In an implementation configured for remote operation, any of a varietyof sensors may be provided to detect clot passing through the aspirationline and/or trapped in the filter, such as an optical sensor, pressuresensor, flow rate sensor, ultrasound sensor or others known in the art.

In some embodiments, the second port 320 is configured to connect to afirst end of a second tube 350 that is fluidly connected to anaspiration source (e.g., a pump). In some embodiments, the second tube350 includes a connector 352 positioned at a second end of the secondtube 350 that is configured to engage or mate with a correspondingconnector on the pump.

In some examples, the system 300 can include an on-off valve 360 such asa clamp 360. The clamp 360 can be positioned in between the filter 330and the patient, such as over the first tube 340 to allow the user toengage the clamp and provide flow control by isolating the patient fromthe clot retrieval device 370. Closing the valve 360 and operating theremote vacuum pump (not illustrated) causes the canister associated withthe vacuum pump and the chamber 381 to reach the same low pressure. Dueto the short distance and small line volume of the lumen between thechamber 381 end the distal end of the catheter, a sharp negativepressure spike is experienced at the distal end of the catheter rapidlyfollowing opening of the valve 360. Additional details are disclosed inU.S. Pat. No. 11,259,821 issued Mar. 1, 2022 to Buck et al., entitledAspiration System with Accelerated Response, the entirety of which ishereby expressly incorporated by reference herein. In some embodiments,a vacuum may be cycled against a clot to retrieve the clot. The vacuummay be automatically and robotically controlled to remove the clot.

The body 380 can have a top surface spaced apart from a bottom surfaceby a tubular side wall. In the illustrated implementation, the top andbottom surfaces are substantially circular, and spaced apart by acylindrical side wall. The top surface may have a diameter that is atleast about three times, or five times or more than the axial length(transverse to the top and bottom surfaces) of the side wall, to producea generally disc shaped housing. Preferably at least a portion of thetop wall is optically transparent to improve clot visualization once itis trapped in the clot retrieval device 370. Additional details may befound in U.S. Patent Application No. 63/256,743, the entirety of whichis hereby incorporated by reference herein.

In some examples, the body 380 can include a flush port (notillustrated) that is configured to allow the injection of an opticallytransparent media such as air, saline or other fluid into the chamber381 to clear an optical path between the window and the filter toimprove clot visualization once it is trapped in the filter 330.

The foregoing represents certain specific implementations of a drivetable and associated components and catheters. A wide variety ofdifferent drive table constructions can be made, for supporting andaxially advancing and retracting two or three or four or more drivemagnet assemblies to robotically drive interventional devices, fluidelements, and electrical umbilical elements for communicating electricalsignals and fluids to the catheter hubs, as will be appreciated by thoseof skill in the art in view of the disclosure herein. Additional detailsmay be found in U.S. patent application Ser. No. 17/527,393, theentirety of which is hereby incorporated by reference herein.

While the foregoing describes robotically driven interventional devicesand manually driven interventional devices, the devices may be manuallydriven, robotically driven, or a combination of both manually androbotically driven interventional devices, as will be appreciated bythose of skill in the art in view of the disclosure herein.

FIGS. 16A-16C illustrate an example control mechanism 2200 formanipulating interventional devices driven by (or otherwise associatedwith) respective hubs. For example, each hub may be manipulated and/orotherwise moved using at least one control installed in controlmechanism 2200. Each control may be adapted to move a unique hub andassociated interventional device during an interventional procedure.

As shown in FIG. 16A, the control mechanism 2200 include a first control2202, a second control 2204, a third control 2206, and a fourth control2208. More or fewer controls may be provided, depending upon theintended interventional devices configuration. Each control 2202-2208 ismovably carried on a shaft 2210 that is coupled to a distal bracket 2212and to a proximal bracket 2214. The controls 2202-2208 may advancedistally or retract proximally on the shaft 2210, as indicated by arrow2218 and arrow 2216. In addition, each control 2202-2208 may also berotated about the shaft 2210, as indicated by arrow 2220. Each controlmovement may trigger a responsive movement in a corresponding carriageon the support table, which may in turn drive movement of acorresponding hub as has been discussed.

The control mechanism 2200 may be positioned on or near to a patientsupport table having a set of hubs and catheters/interventional devices.In some implementations, the control mechanism 2200 may be positionedremote from the support table such as behind a radiation shield or in adifferent room or different geographical location in a telemedicineimplementation.

Each control 2202-2208 may correspond to and drive movement of a huband/or a hub and interventional device combination. For example, thecontrol 2202 may be configured to drive hub 30 (FIG. 3F) to move aninterventional device such as an 0.088 inch guide catheter correspondingto the hub 30. Similarly, the control 2204 may be configured to drivehub 28 (122) to move an interventional device such as an 0.071 inchprocedure catheter. The control 2206 may be configured to drive hub 126to move an interventional device such as a steerable access catheter.The control 2208 may be configured to drive hub 26 to axially androtationally move an interventional device such as a guidewire.

FIG. 16B illustrates an example of manually manipulating the control2202 on control mechanism 2200. In operation, if the user 2230 moves thecontrol 2202 axially along shaft 2210 and distally, as shown by arrow2232, a corresponding coupled hub and/or interventional device may moveresponsively in the same direction by a same or scaled amount. If theuser 2230 rotates the control 2202 about the shaft 2210 and advances thecontrol proximally, as shown by arrow 2234, a corresponding coupledinterventional device will responsively move rotationally and proximallyby a same or scaled amount. If the user 2230 moves the control 2202rotationally about the shaft 2210, as shown by arrow 2236 or arrow 2238,a corresponding coupled hub will drive the corresponding interventionaldevice rotationally in the same direction and/or by a same or scaledamount.

Other axes and degrees of freedom may be defined to enable control 2202to perform movements that may be translated to movement of hubs and/orinterventional devices. For example, the control mechanism may beprovided with one or more deflection controls configured to initiate alateral deflection in a deflection zone on the correspondinginterventional device.

Axial movement of a control may be configured to move the coupled hub ona 1:1 basis, or on a non 1:1 scaled basis. For example, if the user 2230advances the control 2022 about 5 millimeters distally along the shaft2210, then the corresponding hub may responsively move 5 millimeters inthe distal direction.

If the user 2230 rotates the control 2022 about its rotational axis by 5degrees, the coupled hub will cause the corresponding interventionaldevice to rotate on a 1:1 basis or on a non 1:1 scaled basis. The scaledamount may be selected to reduce or increase the amount of distance androtation that a hub and/or interventional device moves in accordancewith the control movement.

In some implementations, the scaled amount described herein may bedetermined using a scale factor. The scale factor may apply to one orboth translational and rotational movement. In some implementations, afirst scale factor is selected for translational movement and a secondscale factor, different than the first scale factor, is selected forrotational movement. The axial scaling factor may drive proximalcatheter movement at a faster speed than distal catheter movement for agiven proximal or distal manipulation of the control.

The rotational scale factor may be 1:1 while the axial scale factor maymove the hub by a greater distance than movement of the control suchthat hub travel to control travel is at least about 2:1 or 5:1 or 10:1or more depending upon the desired axial length of the control assembly.

The control mechanism 2200 may be configured to enable the clinician toadjust the scale factor for different parts of the procedure. Forexample, distal advance of the procedure catheter and access catheterthrough the guide catheter and up to the selected ostium may desirablybe accomplished in a ‘fast’ mode. But more distal travel into the neurovasculature may desirably be accomplished in a relatively slow mode byactuation of a speed control.

In another implementation, one or more controls may be configured toprogressively drive advance or retraction speeds of the correspondinghub and associated catheter. For example, distal control 2202 may drivethe guide catheter. A slight distal movement of the control 2202 mayadvance the guide catheter distally at a slow speed, while advancing thecontrol 2202 by a greater distance distally increases the rate of distaltravel of the guide catheter.

Controlling the speed of the corresponding hubs either axially or bothaxially and rotationally may enhance the overall speed of the procedure.For example, advance of the various devices from the femoral accesspoint up to the aortic arch may desirably be accomplished at a fasterrate than more distal navigation closer to the treatment site. Alsoproximal retraction of the various devices, particularly the guidewire,access catheter and procedure catheter may be desirably accomplished ata relatively higher speeds than distal advance.

FIG. 16C illustrates another example of manually manipulating a controlon the control mechanism 2200 to move hubs and/or other interventionaldevices. In some implementations, two or more controls 2202-2208 may bemoved in combination to trigger movement of one or more hubs and/orrelated interventional devices. In the depicted example, the user 2230moves control 2204 and control 2206 in combination (e.g., sequentially,simultaneously) such as to simultaneously move the 0.088 guide catheterand the 0.071 aspiration catheter as a unit. Example movement of control2204 may include axial proximal movement in the directions shown byarrows 2250. Sequentially or simultaneously, the user 2230 may movecontrol 2206 axially in either of the directions shown by arrows 2254and 2256 while also moving control 2206 rotationally in either of thedirections shown by arrows 2258 and 2260.

In some implementations, each control mechanism and/or additionalcontrols (not shown) may be color coded, shaped coded, tactile coded, orother coding to indicate to the user 2230 which color is configured tomove which hub or interventional device. In some implementations, thecontrol color coding may also be applied to the hubs and/orinterventional devices such that a user may visually match a particularhub/device with a particular control.

In some implementations, other control operations beyond translationalmovement and rotational movement may be carried out using controls2202-2208. For example, controls 2202-2208 may be configured to drive ashape change and/or stiffness change of a corresponding interventionaldevice. Controls 2202-2208 may be toggled between different operatingmodes. For example, controls 2202-2208 may be toggled between movementdriven by acceleration and velocity to movement that reflects actuallinear displacement or rotation.

In some implementations, the control mechanism 2200 may be provided witha visual display or other indicator of the relative positions of thecontrols which may correspond the relative positions of theinterventional devices. Such displays may depict any or all movementdirections, instructions, percentage of movements performed, and/or huband/or catheter indicators to indicate which device is controlled by aparticular control. In some implementations, the display may depictapplied force or resistance encountered by the catheter or othermeasurement being detected or observed by a particular hub orinterventional component.

In some implementations, the control mechanism 2200 may include hapticcomponents to provide haptic feedback to a user operating the controls.For example, if the control 2202 is triggering movement of a catheterand the catheter detects a large force at the tip, the control 2202 maygenerate haptic feedback to indicate to the user to stop or reverse aperformed movement. In some implementations, haptic feedback may begenerated at the control to indicate to the user to slow or speed amovement using the control. In some implementations, haptics may providefeedback on a large torsional strain buildup that might precede anabrupt rotation, or a large axial force buildup that may be a prelude tobuckling of the catheter.

The systems described herein may compare an actual fluoroscopic imageposition to an input displacement from the controller. A staticfluoroscopic image of the patient may be captured in which the patient'svasculature is indexed relative to bony landmarks or one or moreimplanted soft tissue fiducial markers. Then a real time fluoroscopicimage may be displayed as an overlay, aligned with the static image byregistration of the fiducial markers. Visual observation of conformanceof the real time movement with the static image, assisted by detectedforce data can help confirm proper navigation of the associated catheteror guidewire. The systems described herein can also display a comparisonof an input proximal mechanical translation of a catheter or guidewireand a resulting distal tip output motion or lack thereof. A loss ofrelative motion at the distal tip may indicate shaft buckling, prolapse,kinking, or a similar outcome, either inside or outside the body. Such acomparison may be beneficial when the shaft buckling, prolapse, kinking,or similar outcome occurs outside of a current fluoroscopic view.

FIG. 17 illustrates a side elevational schematic view of a multicatheter interventional device assembly 2900 for combined supra-aorticaccess and/or neurovascular site access and procedure (e.g.,aspiration), as described herein. The multi catheter assembly 2900 maybe configured for either a manual or a robotic procedure.

The interventional device assembly 2900 includes an insert or accesscatheter 2902, a procedure catheter 2904, and a guide catheter 2906.Other components are possible including, but not limited to, one or moreguidewires (e.g., optional guidewire 2907), one or more guide catheters,an access sheath and/or one or more other procedure catheters and/orassociated catheter (control) hubs. In some embodiments, the assembly2900 may also be configured with an optional deflection control 2908 forcontrolling deflection of one or more catheters of assembly 2900.

In operation, the multi-catheter assembly 2900 may be used withouthaving to exchange hub components. For example, in the two stageprocedure disclosed previously, a first stage for achieving supra-aorticaccess, includes mounting an access catheter, guide catheter andguidewire to the support table. Upon gaining supra aortic access, theaccess catheter and guidewire were typically removed from the guidecatheter. Then, a second catheter assembly is introduced through theguide catheter after attaching a new guidewire hub and a procedurecatheter hub to the corresponding drive carriage on the support table.

The single multi catheter assembly 2900 of FIG. 17 is configured to beoperated without having to remove hubs and catheters and without theaddition of additional assemblies and/or hubs. Thus, the multicomponentaccess and procedure configuration of assembly 2900 may utilize aguidewire 2907 manufactured to function as an access guidewire and anavigation guidewire to allow for sufficient access and support, andnavigation to the particular distal treatment site. In a non-limitingexample configured for robotic implementation, a catheter assembly mayinclude a guidewire hub (e.g., guidewire hub 2909 or guidewire hub 26positioned on a drive table and to the right of catheter 2902), aninsert or access catheter hub 2910, a procedure catheter hub 2912, aguide catheter hub 2914 and corresponding catheters. In certainembodiments, one or more of the hubs may include or be coupled to ahemostasis valve (e.g., a rotating hemostasis valve) to accommodateintroduction of interventional devices therethrough. Additional detailsregarding hemostasis valves are included in U.S. patent application Ser.No. 17/879,614, entitled Multi Catheter System With Integrated FluidicsManagement, filed Aug. 2, 2022, which is hereby expressly incorporatedin its entirety herein

Once access above the aortic arch has been achieved, the insert oraccess catheter 2902 (associated with insert catheter hub 2910) may beparked in the vicinity of a carotid artery ostia and the remainder or asubset of the catheter assembly may be guided more distally toward aparticular site (e.g., a clot site, a surgical site, a procedure site,etc.).

In some embodiments, other smaller procedure catheters may also be addedand used at the site. As used herein for catheter assembly 2900, in arobotic configuration of assembly 2900, the catheter 2906 may functionas a guide catheter. The catheter 2904 may function as a procedure(e.g., aspiration) catheter. In some embodiments, the catheter 2906 mayfunction to perform aspiration in addition to functioning as a guidecatheter, either instead of or in addition to the catheter 2904. Theaccess catheter 2902 may have a distal deflection zone and can functionto access a desired ostium. One of skill in the art will appreciate fromFIGS. 18A-18E that either manual manipulation or robotic manipulation ofthe multi catheter stack are contemplated herein.

In some embodiments, the catheter assembly 2900 (or other combinedcatheter assemblies described herein) may be driven as a unit to alocation. However, each catheter (or guidewire) component may instead beoperated and driven independent of one another to the same or differentlocations.

In a non-limiting example, the catheter assembly 2900 may be used for adiagnostic angiogram procedure. In some embodiments, the assembly 2900may include only the guidewire 2907 and access catheter 2902 (in theform of a diagnostic angiographic catheter) for performing thediagnostic angiogram procedure or only the guidewire 2907 and the accesscatheter 2902 may be utilized during the procedure. Alternatively, theguide catheter 2906 and procedure catheter 2904 may be retractedproximally to expose the distal end of the access catheter 2902 (e.g., afew centimeters of the distal end of the access catheter) to perform thediagnostic angiography.

As shown in FIG. 17 , the guide catheter 2906, procedure catheter 2904,access catheter 2902, and guidewire 2907 can be arranged concentrically.In certain embodiments, the guide catheter 2906 may be a ‘large bore’guide catheter or access catheter having a diameter of at least about0.075 or at least about 0.080 inches in diameter. The procedure catheter2904 may be an aspiration catheter having a diameter within the range offrom about to about 0.075 inches. The access catheter 124 may be asteerable catheter with a deflectable distal tip, having a diameterwithin the range of from about 0.025 to about 0.050 inches. Theguidewire 2907 may have a diameter within the range of from about 0.014to about 0.020 inches. In one example, the guide catheter 2906 may havea diameter of about inches, the procedure catheter 2904 about 0.071inches, the access catheter 2902 about inches, and the guidewire 2907may have a diameter of about 0.018 inches.

FIGS. 18A-18E depict an example sequence of steps of introducing amulti-catheter assembly configured to achieve access all the way to theclot, either manually or robotically. FIGS. 18A-18E may be describedusing the interventional device assembly of FIG. 17 . Other combinationsof catheters may be substituted for the interventional device assembly,as will be appreciated by those of skill in the art in view of thedisclosure herein.

Referring to FIG. 18A, the three catheter interventional device assembly2900 is shown driven through an introducer sheath 3002, up through theiliac artery 3004 and into the descending aorta. Next, the accesscatheter 2902, the procedure catheter 2904 (e.g., 0.071 inch) and theguide catheter 2906 (e.g., 0.088 inch) are tracked up to the aortic arch3006, as shown in FIG. 18B. Here, the distal end of the guide catheter2906 may be parked below the aortic arch 3006 and the procedure catheter2904, access catheter 2902 (positioned within the procedure catheter2904 and not visible in FIG. 18B), and a guidewire 2907 can be driveninto the ostium (e.g., simultaneously or separately). In someembodiments, the access catheter 2902 is advanced out of the procedurecatheter 2904 and the guide catheter 2906 to engage the ostium first.After the distal end of the access catheter 2902 is positioned withinthe desired ostium, the guidewire 2907 can be advanced distally into theostium to secure access. After the access catheter 2902 and guidewire2907 are positioned within the desired ostium, the procedure catheter2904 and/or guide catheter 2906 can be advanced into the ostium (and, insome embodiments, beyond), while using the support of the accesscatheter 2902 and/or guidewire 2907 to maneuver through the aorta andinto the ostium. In the embodiment shown in FIG. 18B, the procedurecatheter 2904 has been advanced into the ostium while the guide catheter2906 has remained parked below the aortic arch 3006.

Referring to FIG. 18C, the guidewire 2907 may be distally advanced andthe radiopacity of the guidewire 2907 may be used to confirm underfluoroscopic imaging that access through the desired ostia has beenattained. The guidewire 2907 engages the origin of the brachiocephalicartery 3014. The guidewire 2907 is then advanced up to the petroussegment 3018 of the internal carotid artery 3016.

Referring to FIG. 18D, the guide catheter 2906 and the procedurecatheter 2904 (positioned within the guide catheter 2906 and not visiblein FIG. 18D) are both advanced (e.g., simultaneously or sequentially)over the guidewire 2907 and over the insert or access catheter 2902(positioned within the procedure catheter 2904 and not visible in FIG.18D) while the access catheter 2902 remains at the ostium for support.The guidewire 2907 may be further advanced past the petrous segment 3018to the site of the clot 3020, such as the M1 segment.

Referring to FIG. 18E, the guide catheter 2906 and the procedurecatheter 2904 (positioned within the guide catheter 2906 and not visiblein FIG. 18E) are advanced (e.g., simultaneously or sequentially) toposition the distal tip of the procedure catheter 2904 at the proceduresite, for example on the face of the clot 3020. The guidewire 2907 andaccess catheter 2902 (positioned within the procedure catheter 2904 andnot visible in FIG. 18E) are removed, and aspiration of the clot 3020commences through the procedure catheter 2904. That is, the guidewire2907 and the access catheter 2902 are proximally retracted to allowaspiration through the procedure catheter 2904. After aspiration of theclot, the procedure catheter 2904 and guide catheter 2906 can be removed(e.g., simultaneously or sequentially). For example, in someembodiments, the procure catheter 2904 may be removed before removingthe guide catheter 2906.

The catheter assembly 2900 may be used to perform a neurovascularprocedure, as described in FIGS. 18A-18E. For example, the neurovascularprocedure may be a neurovascular thrombectomy. The steps of theprocedure may include providing an assembly that includes at least aguidewire, an access catheter, a guide catheter, and a procedurecatheter. For example, the catheter assembly 2900 includes a guidewire2907, an access (e.g., insert) catheter 2902, a guide catheter 2906, andat least one procedure catheter 2904. The procedure catheter 2904 mayinclude an aspiration catheter, an embolic deployment catheter, a stentdeployment catheter, a flow diverter deployment catheter, a diagnosticangiographic catheter, a stent retriever catheter, a clot retrievercatheter, a balloon catheter, a catheter to facilitate percutaneousvalve repair or replacement, an ablation catheter, and/or an RF ablationcatheter or guidewire.

The neurovascular procedure may further include steps of coupling theassembly to a non-robotic or a robotic drive system, and driving theassembly to achieve supra-aortic access. The steps may further includedriving a subset of the assembly to a neurovascular site, and performingthe neurovascular procedure using a subset of the assembly. The subsetof the assembly may include the guidewire, the guide catheter, and theprocedure catheter.

Each of the guidewire 2907, the access catheter 2902, the guide catheter2906, and the procedure catheter 2904 is configured to be adjusted by arespective hub. For example, the guidewire 2907 may include (or becoupled to) a hub installed on one of the tray assemblies describedherein. Similarly, the access catheter 2902 may be coupled to catheterhub 2910. The guide catheter 2906 may be coupled to the guide catheterhub 2914. The procedure catheter 2904 may be coupled to the procedurecatheter hub 2912.

In general coupling of the assembly may include magnetically coupling afirst hub 2909 on the guidewire 2907 to a first drive magnet,magnetically coupling a second hub 2910 on the access catheter 2902 to asecond drive magnet, magnetically coupling a third hub 2912 on theprocedure catheter 2904 to a third drive magnet, and magneticallycoupling a fourth hub 2914 on the guide catheter 2906 to a fourth drivemagnet. In general, the first drive magnet, the second drive magnet, thethird drive magnet, and the fourth drive magnet are each independentlymovably carried by a drive table, as described with respect to trayassemblies and controls described herein. In some embodiments, the firstdrive magnet, the second drive magnet, the third drive magnet, and thefourth drive magnet are coupled (e.g., to their respective catheterhubs) through a sterile barrier (e.g., a sterile and fluid barrier) andindependently movably carried by a drive table having a plurality ofdriven magnets. In some embodiments, two or more drive magnets can betethered or otherwise coupled together to move as a unit in response tocommands from a single controller tethered or otherwise coupled to oneof the drive magnets.

In some implementations, the steps of performing the neurovascularprocedure may include driving the assembly in response to movement ofeach of the hub adapters along a support table until the assembly ispositioned to achieve supra-aortic vessel access. The hub adapters mayinclude, for example, a coupler/carriage that acts as a shuttle byadvancing proximally or distally along a track in response to operatorinstructions. The hub adapters described herein may each include atleast one drive magnet configured to couple with a driven magnet carriedby the respective hub. This provides a magnetic coupling between thedrive magnet and driven magnet through the sterile barrier such that therespective hub is moved across the top of the sterile barrier inresponse to movement of the hub adapter outside of the sterile field (asdescribed in detail in FIG. 4 ). Movement of the hub adapter is drivenby a drive system carried by the support table in which the guidewirehub 2909, the guide catheter hub 2914, the procedure catheter hub 2912,and the access catheter hub 2910 are installed upon.

The steps may further include driving a subset of the assembly inresponse to movement of each of the hub adapters along the support tableuntil the subset of the assembly is positioned to perform aneurovascular procedure at a neurovascular treatment site. The subset ofthe assembly may include the guidewire 2907, the guide catheter 2906,and the procedure catheter 2904.

In some embodiments, the guidewire 2907, the guide catheter 2906 and theprocedure catheter 2904 are advanced as a unit through (with respect tothe guidewire 2907) and over (with respect to the guide catheter 2906and the procedure catheter 2904) at least a portion of a length of theaccess (e.g., insert) catheter 2902 after supra-aortic access isachieved.

In some embodiments, the catheter assembly 2900 may be part of a roboticcontrol system for achieving supra-aortic access and neurovasculartreatment site access, as described in FIGS. 18A-18E. In someembodiments, the catheter assembly 2900 may be part of a manual controlsystem for achieving supra-aortic access and neurovascular treatmentsite access. In some embodiments, the catheter assembly 2900 may be partof a hybrid control system (with manual and robotic components) forachieving supra-aortic access and neurovascular treatment site access.For example, in such hybrid systems, supra-aortic access may berobotically driven while neurovascular site access and embolectomy orother procedures may be manual. Alternatively, in such hybrid systems,supra-aortic access may be manual while neurovascular site access may berobotically achieved. Still further, in such hybrid systems, any one ormore of: the guidewire, access catheter, guide catheter, or procedurecatheter may be robotically driven or manually manipulated.

An example robotic control system may include at least a guidewire hub(e.g., guidewire hub 2909) configured to adjust each of an axialposition and a rotational position of a guidewire 2907. The roboticcontrol system may also include an access catheter hub 2910 configuredto adjust axial and rotational movement of an access catheter 2902. Therobotic control system may also include a guide catheter hub 2914configured to control axial movement of a guide catheter 2906. Therobotic control system may also include a procedure catheter hub 2912configured to adjust an axial position and a rotational position of aprocedure catheter 2904.

In some embodiments, the procedure catheter hub 2912 is furtherconfigured to laterally deflect a distal deflection zone of theprocedure catheter 2904.

In some embodiments, the guidewire hub 2909 is configured to couple to aguidewire hub adapter by magnetically coupling the guidewire hub to afirst drive magnet. The access catheter hub 2910 is configured to coupleto an access catheter hub adapter by magnetically coupling the accesscatheter hub 2910 to a second drive magnet. The procedure catheter hub2912 is configured to couple to a procedure catheter hub adapter bymagnetically coupling the procedure catheter hub 2912 to a third drivemagnet. The guide catheter hub 2914 is configured to couple to a guidecatheter hub adapter by magnetically coupling the guide catheter hub2914 to a fourth drive magnet. In some embodiments, the first drivemagnet, the second drive magnet, the third drive magnet, and the fourthdrive magnet are independently movably carried by a drive table.

In some embodiments, the robotic control system includes a first drivenmagnet on the guidewire hub 2909. The first driven magnet may beconfigured to cooperate with the first drive magnet such that the firstdriven magnet is configured to move in response to movement of the firstdrive magnet. In some embodiments, the first drive magnet is configuredto move outside of a sterile field separated from the first drivenmagnet by a barrier while the first driven magnet is within the sterilefield. In some embodiments, a position of the first driven magnet ismovable in response to manipulation of a procedure drive control on acontrol console associated with the drive table. Drive magnets anddriven magnet interactions are described in detail in FIG. 4 above.

In some embodiments, the robotic control system includes a second drivenmagnet on the access catheter hub 2910. The second driven magnet may beconfigured to cooperate with the second drive magnet such that thesecond driven magnet is configured to move in response to movement ofthe second drive magnet. In some embodiments, the second drive magnet isconfigured to move outside of a sterile field separated from the seconddriven magnet by a barrier while the second driven magnet is within thesterile field.

In some embodiments, the robotic control system includes a third drivenmagnet on the procedure catheter hub 2912. The third driven magnet maybe configured to cooperate with the third drive magnet such that thethird driven magnet is configured to move in response to movement of thethird drive magnet. In some embodiments, the third drive magnet isconfigured to move outside of a sterile field separated from the thirddriven magnet by a barrier while the third driven magnet is within thesterile field.

In some embodiments, the robotic control system includes a fourth drivenmagnet on the guide catheter hub 2914. The fourth driven magnet may beconfigured to cooperate with the fourth drive magnet such that thefourth driven magnet is configured to move in response to movement ofthe fourth drive magnet. In some embodiments, the fourth drive magnet isconfigured to move outside of a sterile field separated from the fourthdriven magnet by a barrier while the fourth driven magnet is within thesterile field. In some embodiments, there may be more than four drivenmagnets and corresponding catheter hubs for control of additionalcatheters.

In some embodiments, devices (e.g., hubs, hub adapters, interventionaldevices, and/or trays) described herein may be used during a roboticallydriven procedure. For example, in a robotically driven procedure, one ormore of the interventional devices may be driven through vasculature andto a procedure site. Robotically driving such devices may includeengaging electromechanical components that are controlled by user input.In some implementations, users may provide the input at a control systemthat interfaces with one or more hubs and hub adapters.

In some embodiments, the hubs, hub adapters, interventional devices, andtrays described herein may be used during a non-robotic (e.g., manuallydriven) procedure. Manually driving such devices may include engagingmanually with the hubs to affect movement of the interventional devices.

In some embodiments, the devices described herein may be used to carryout a method of performing an intracranial procedure at an intracranialsite. The method of performing the intracranial procedure may includeany of the same steps as described herein for performing a neurovascularprocedure. The procedure may be robotically performed, manuallyperformed, or a hybridized combination of both.

While the foregoing describes magnetic coupling of hubs to drivemagnets, in other embodiments, any of the interventional devices and/orhubs may be mechanically coupled to a drive system. Any of the methodsdescribed herein may include steps of mechanically coupling one or moreinterventional devices (e.g., the guidewire 2907, the access catheter2902, the procedure catheter 2904, and/or the guide catheter 2906)and/or one or more hubs (e.g., the guidewire hub 2909, the accesscatheter hub 2910, the procedure catheter hub 2912, and/or the guidecatheter hub 2914) with one or more drive mechanisms.

FIG. 19 illustrates a mechanical coupling mechanism 1654 between a drivemechanism 1650 and a driven mechanism 1652. Drive mechanism 1650 anddriven mechanism 1652 may have any of the same or similar features orfunctions as the drive magnet 67 and driven magnet 69, respectively,except as otherwise described herein. The drive mechanism 1650 may bepart of or coupled to a hub adapter (e.g., the hub adapter 48). Thedriven mechanism 1652 may be part of or coupled to a hub (e.g., the hub36, the guidewire hub 2909, the access catheter hub 2910, the procedurecatheter hub 2912, or the guide catheter hub 2914). In some instances,the mechanical coupling mechanism 1654 may comprise a structural support(e.g., a support rod or support strut) extending transversely through aseal in a sterile barrier 1632. The seal may permit the structuralsupport to be advanced along a length of the sterile barrier 1632, whilestill maintaining a seal with the structural support to maintain thesterile field, as the drive mechanism 1650 and driven mechanism 1652 areadvanced and/or retracted as described herein. For example, the seal maycomprise a tongue and groove closure mechanism along the sterile barrier1632 that is configured to close on either side of the structuralsupport while permitting passage of the structural support through thesterile barrier 1632 and maintaining a seal against the structuralsupport as the structural support is advanced along the length of thesterile barrier 1632.

In some embodiments, the structural support can extend through anelongate self closing seal between two adjacent coaptive edges offlexible material (e.g., similar in shape to a duckbill valve) thatextends along an axis. As the structural support advances along the axisbetween the copative edges, the coaptive edges may permit the structuralsupport to advance, and then may be biased back into a sealingengagement with each other as the structural support passes any givenpoint along the axis.

In some embodiments, the drive mechanism may be a splined drive shaft(e.g., a non-sterile splined drive shaft). The mechanical coupling 1654can include a pulley within a plate that serves as the sterile barrier1632 and a sterile splined shaft configured to couple to the drivenmechanism 1652. The driven mechanism 1652 can be a sterile pulley thatreceives the sterile splined shaft from the sterile barrier. In someembodiments, one or more splined drive shafts can engage and turncorresponding pulleys in the plate that serves as the sterile barrier.Each hub can have a sterile pulley that is configured to receive asterile splined shaft from the sterile barrier plate. Rotation of thesplined drive shaft can turn the pulley in the sterile barrier platewhich can in turn the sterile pulley in the hub via the sterile splinedshaft.

It will be understood by one having skill in the art that any embodimentas described herein may be modified to incorporate a mechanical couplingmechanism, for example, as shown in FIG. 19 .

The interventional devices described herein may be provided individuallyor at least some of the interventional devices can be provided in apreassembled (e.g., nested or stacked) configuration. For example, theinterventional devices may be provided in the form of an interventionaldevice assembly, such as interventional device assembly 2900, in aconcentric nested or stacked configuration. If provided individually,each catheter (and in some embodiments, each corresponding catheter hub)can be unpackaged and primed to remove air from its inner lumen, forexample, by flushing the catheter (and in some embodiments, thecorresponding catheter hub) to remove air by displacing it with a fluid,such as saline. After priming, the interventional devices can bemanually assembled into a stacked configuration so that they are readyfor introduction into the body for a surgical procedure, for example,via an introducer sheath.

Assembling the devices into a stacked configuration can includeindividually inserting interventional devices into one another by orderof size. For example, an interventional device having a second largestdiameter can be inserted into the lumen of an interventional devicehaving a largest diameter. An interventional device having a thirdlargest diameter can then be inserted into the interventional devicehaving the second largest diameter and so on.

For example, with respect to FIG. 17 , assembly can be performed byfirst inserting a distal end of the catheter 2904 through the hub 2914and into the catheter 2906. The catheter 2904 can be advanced throughthe catheter 2906 until the distal tip of the catheter 2904 is flushwith or extends beyond the distal tip of the catheter 2906. Then, thedistal end of the catheter 2902 can be inserted through the hub 2912 andinto the catheter 2904. The catheter 2902 can be advanced through thecatheter 2904 until the distal tip of the catheter 2902 is flush with orextends beyond the distal tip of the catheter 2904. Then, the distal endof the guidewire 2907 can be inserted through the hub 2910 and into thecatheter 2902. The guidewire 2907 can be advanced through the catheter2902 until the distal tip of the guidewire 2907 is flush with or extendsbeyond the distal tip of the catheter 2902.

Embodiments in which two or more of the interventional devices arepackaged together as a single unit in an assembled (e.g., nested orstacked) configuration may provide efficient unpackaging prior to useand efficient assembly within a robotic control system. Theinterventional devices may be pre-mounted to their respective hubs priorto packaging. In certain embodiments, two or three or moreinterventional devices may be packaged in a fully nested (i.e., fullyaxially inserted) configuration or nearly fully nested configuration. Ina fully nested configuration, each interventional device is inserted asfar as possible into an adjacent distal hub and interventional device.Such a fully nested configuration may minimize a total length of theinterventional device assembly and minimize the size of the packagingrequired to house the interventional device assembly.

The interventional devices may also be sterilized prior to packagingwhile in the assembled configuration, for example, using ethylene oxidegas. For interventional devices in a nested or stacked configuration,ethylene oxide gas can be provided in a space between adjacentinterventional devices (for example, an annular lumen between an outerdiameter of a first interventional device nested within a secondinterventional device and the inner diameter of the secondinterventional device) for sterilization. In some embodiments, theinterventional device assembly can be packaged in a thermoformed trayand sealed with an HDPE (e.g., Tyvek®) lid. The interventional deviceassembly can be unpackaged by removal (e.g., opening or peeling off) ofthe lid by a user in a non-sterile field. A user in the sterile fieldcan then remove the interventional device assembly and place it on thesterile work surface, for example, of a robotic drive table, asdescribed herein.

Packaging the interventional devices in an assembled configuration andsterilized state can reduce the time associated with unpackaging andassembly of individual interventional devices and facilitate efficientconnection to a robotic drive system. Each interventional device and hubcombination may further be packaged with a fluidics connection forcoupling to a fluid source and/or a vacuum source. In some embodiments,each hub or a hemostasis valve coupled to the hub may include thefluidics connection.

After the interventional device assembly is unpackaged (e.g., after theinterventional device assembly is positioned on the robotic drivetable), priming can be performed while the devices are concentricallynested or stacked. This is preferably accomplished in each fluid lumen,such as, for example, the annular lumen between the catheter 2906 andthe catheter 2904 and in between each of the additional concentricinterventional devices in the concentric stack. In certain embodiments,the fluid lumen can include a lumen between a distal hub and a proximalinterventional device, such as, for example, the lumen between the hub2914 and the catheter 2904.

The fluidics connections can be connected to a fluidics system fordelivering saline and contrast media to the catheters and providingaspiration. In some embodiments, the fluidics connections may be passedoutside the sterile field for connection to the fluidics system. Onceconnected, the fluidics system can perform a priming sequence to flusheach catheter of the interventional device assembly with saline. Thepriming sequence may also include flushing each corresponding catheterhub with saline. The saline may be de-aired or de-gassed by the fluidicssystem prior to priming. In some embodiments, a vacuum source of thefluidics system can also be used to evacuate air from each catheterwhile flushing with saline. In certain embodiments, a tip of thecatheter can be placed into a container of fluid, such as saline, duringpriming so that the fluid in the container, and not air, is aspiratedthrough the tip of the catheter when the vacuum source is applied. Inother embodiments, the tip of the catheter may be blocked (for example,using a plug) so that air is not aspirated from the tip of the catheterwhen the vacuum source is applied. In certain embodiments, the primingprocess may be automated such that a user can provide a single commandand each catheter (and in some embodiments, each corresponding catheterhub) can be primed, sequentially (for example, as described with respectto FIGS. 20A-20C) or simultaneously.

Additional details regarding fluidics systems are disclosed in U.S.patent application Ser. No. 17/879,614, entitled Multi Catheter SystemWith Integrated Fluidics Management, filed Aug. 2, 2022, which is herebyexpressly incorporated in its entirety herein.

Fluid resistance within a lumen may be greater when there is a reductionin cross sectional luminal area for flow, for example, when a secondinterventional device (e.g., a catheter or guidewire) extends within thelumen of a first interventional device. The amount of fluid resistancecan be affected by the length of the cross sectional narrowing, forexample, due to a depth of axial insertion of the second interventionaldevice within the first interventional device. A second interventionaldevice extending partially through the lumen of a first interventionaldevice will provide a smaller length of cross-sectional narrowing, andaccordingly may result in a lower fluid resistance within the lumen ofthe first catheter, than if the second interventional device were toextend entirely through the lumen of the first interventional device.Thus, fluid resistance can be lowered by at least partially decreasing adepth of axial insertion (i.e., axial overlap) of a secondinterventional device into the lumen through which fluid is to beinjected (e.g., a length of the second interventional device into itsconcentrically adjacent lumen).

In some embodiments, over certain depths of insertion of a secondinterventional device within a first interventional device (for example,when the second interventional device is at or near a maximum insertiondepth within the first interventional device), the size of the fluidchannel between the devices (e.g., the annular lumen between the firstinterventional device and the second interventional device) can lead tohigher than desirable amounts of fluid resistance during a primingprocedure. In some embodiments, the depth of insertion of the secondinterventional device within the first interventional device can bedecreased to reduce the pressure needed to prime the catheter and reduceinternal interference.

In some embodiments, a catheter in the interventional device assemblycan be separated from the other interventional devices for priming toreduce the pressure needed to prime the catheter and reduce internalinterference. The catheter being primed may be separated from theinterventional devices within the lumen of the catheter by proximallyretracting the interventional devices within the lumen of the catheter.For example, the interventional devices within the lumen of the catheterbeing primed can be proximally retracted from the catheter being primedas far as possible while still maintaining a nested or stackedrelationship (e.g., at least about 2 cm or 5 cm or more axial overlap)in order to minimize the pressure needed to prime the catheter andminimize internal interference. In other words, a catheter can beseparated from more proximal interventional devices for priming while adistal tip of an adjacent proximal interventional device is stillpositioned within the lumen of the catheter.

In some embodiments, the axial overlap may be between about 2 cm andabout cm, between about 2 cm and 10 cm, between about 2 cm and 5 cm,between about 5 cm and cm, between about 5 cm and 10 cm, or any othersuitable range. In some embodiments, the axial overlap may be at leastabout 2 cm, at least about 5 cm, at least about 10 cm, at least about 20cm, no more than 2 cm, no more than 5 cm, no more than 10 cm, no morethan 20 cm, about 2 cm, about 5 cm, about 10 cm, about 20 cm, or anyother suitable amount.

In some embodiments, the robotic drive table can be programed toproximally retract the inner interventional device(s) from the catheterbeing primed as much as possible while still maintaining a nested orstacked relationship. In other embodiments, the robotic drive table canbe programmed to separate inner devices from the catheter being primedto a distance sufficient to optimize the length of the unobstructedlumen and result in an amount of fluid resistance lower than a thresholdvalue. After the catheter being primed is separated from the otherinterventional devices, the catheter can be primed by flushing thecatheter with fluid, such as saline.

After the catheter is primed, it may be returned to an initial positionand a next catheter of the interventional device assembly can beseparated from the other interventional devices within its lumen forpriming. This sequence can be repeated for each catheter of theinterventional device assembly. While the foregoing describes separatingcatheters to be primed by retraction of inner interventional devices, anouter catheter may also be separated from inner interventional devicesby distally axially advancing the outer catheter relative to the innerinterventional devices. An example of a priming process is describedwith respect to FIGS. 20A-20C.

FIG. 20A depicts the interventional device assembly 2900 assembled in aconcentric stack and axially compressed configuration. As shown in FIG.20A, the interventional devices can be fully nested within each other.This may be the configuration following unpackaging of the deviceassembly 2900 and placement onto the robotic drive table. A primingsequence may begin by distally axially advancing the catheter 2906 andhub 2914 relative to the catheter 2904, hub 2912, catheter 2902, hub2910, guidewire 2907, and hub 2909, for example, as far as possiblewhile maintaining a distal tip of the catheter 2904 within the lumen ofthe catheter 2906, as shown in FIG. 20B, or to a distance that willresult in a desirable amount of fluid resistance for priming. Thecatheter 2906 can then be primed by introducing priming fluid using thefluidics system. Priming the catheter 2906 can include priming the hub2914. For example, in certain embodiments, the hub 2914 or a hemostasisvalve coupled thereto can include fluidics connections to receivepriming fluid from the fluidics system. After priming, the catheter 2906can be returned to its initial position (e.g., the fully axiallycompressed configuration) as shown in FIG. 20A.

After the catheter 2906 is primed and returned to its initial position,the catheter 2904 and hub 2912 can be distally axially advanced relativeto the catheter 2902, hub 2910, guidewire 2907 and hub 2909 (alsodistally axially advancing the catheter 2906 and hub 2914 withoutchanging or minimally changing their relative position with respect tocatheter 2904), for example, as far as possible while maintaining adistal tip of the catheter 2902 within the lumen of the catheter 2904,as shown in FIG. 20C, or to a distance that will result in a desirableamount of fluid resistance for priming. The catheter 2904 can then beprimed by introducing priming fluid using the fluidics system. Primingthe catheter 2904 can include priming the hub 2912. For example, incertain embodiments, the hub 2912 or a hemostasis valve coupled theretocan include fluidics connections to receive priming fluid from thefluidics system. After priming, the catheter 2904 and catheter 2906 canbe returned to their initial positions (e.g., the fully axiallycompressed configuration) as shown in FIG. 20A.

After the catheter 2904 is primed and returned to its initial position,the catheter 2902 and hub 2910 can be distally axially advanced relativeto the guidewire 2907 and hub 2909 (also distally axially advancing thecatheter 2906, hub 2914, catheter 2904, and hub 2912 without changing orminimally changing their relative positions with respect to the catheter2902), for example, as far as possible while maintaining a distal tip ofthe guidewire 2907 within the lumen of the catheter 2902, or to adistance that will result in a desirable amount of fluid resistance forpriming. The catheter 2902 can then be primed by introducing primingfluid using the fluidics system. Priming the catheter 2902 can includepriming the hub 2910. For example, in certain embodiments, the hub 2910or a hemostasis valve coupled thereto can include fluidics connectionsto receive priming fluid from the fluidics system. After priming, thecatheter 2902 and catheters 2904 and 2906 can be returned to theirinitial positions (e.g., the fully axially compressed configuration)shown in FIG. 20A.

In alternative embodiments, each of the catheters can be distallyseparated from one another simultaneously for priming. For example, thecatheter 2902 can be distally separated from the guidewire 2907 whilemaintaining the distal tip of the guidewire 2907 in the lumen of thecatheter 2902, the catheter 2904 can be distally separated from thecatheter 2902 while maintaining the distal tip of the catheter 2902 inthe lumen of the catheter 2904, and the catheter 2906 can be distallyseparated from the catheter 2904 while maintaining the distal tip of thecatheter 2904 in the lumen of the catheter 2906 simultaneously. However,an embodiment in which only one set of adjacent hubs is separated at atime, as described with respect to FIGS. 20A-20C, can provide a smalleroverall length of the assembly at any particular time, which can allowfor use with a smaller robotic drive system. While separation of outercatheters from their inner interventional devices is described asdistally axially advancing the catheters relative to their innerinterventional devices, separation can include proximally retracting theinner interventional devices from the outer catheters.

As described above, in some embodiments, the catheters 2902, 2904, and2906 may be assembled into the concentric stack orientation illustratedin FIG. 17 prior to flushing the catheters to remove air by displacingit with a fluid such as saline. This is preferably accomplished in eachfluid lumen, such as, for example, the annular lumen between thecatheter 2906 and the catheter 2904 and in between each of theadditional concentric interventional devices in the concentric stack.Infusing saline under pressure may displace substantially all of the airbut some small bubbles may remain, adhering to the inside wall of anouter catheter (e.g., the guide catheter 2906), the outside wall of aninner catheter (e.g., the procedure catheter 2904), or both.

While saline is being introduced under pressure into the proximal end ofthe annular lumen (e.g., into a hub of the outer catheter or ahemostasis valve coupled thereto), the inner catheter may be moved withrespect to the outer catheter, to disrupt the holding forces between themicrobubbles and adjacent wall and allow the bubbles to be carrieddownstream and out through the distal opening of the lumen or removedvia aspiration. The catheters may be moved axially, rotationally or bothwith respect to each other. In certain embodiments, the catheters may bereciprocated axially, rotationally, or both with respect to each other.In some embodiments, the catheters may be moved intermittently axially,rotationally, or both. In other embodiments, the catheters may berotated continuously or in a constant direction.

In some implementations, a first catheter is moved reciprocally withrespect to an adjacent catheter or guidewire such as axially over astroke length in a range of from about 1 mm to about 250 mm, from about10 mm to about 250 mm, from about 5 mm to about 125 mm, from about 25 mmto about 125 mm, from about 10 mm to about 50 mm, from about 15 mm toabout 30 mm, from about 5 mm to about 30 mm, from about 15 mm to about25 mm, from about 20 mm to about 40 mm, or any other suitable range. Insome implementations, a first catheter is moved reciprocally withrespect to an adjacent catheter or guidewire such as axially over astroke length of at least 5 mm, at least 10 mm, at least 15 mm, at least20 mm, at least 25 mm, at least 30 mm, at least 50 mm, no more than 10mm, no more than 20 mm, no more than 25 mm, no more than 30 mm, no morethan 50 mm, no more than 125 mm, no more than 150 mm, about 5 mm, about10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 50 mm,or any other suitable stroke length.

In some implementations, a first catheter is moved reciprocally withrespect to an adjacent catheter or guidewire such as axially at areciprocation frequency in a range of from about 0.5 Hz to about 1 Hz,from about 1 Hz to about 5 Hz, from about 1 Hz to about 10 Hz, fromabout 1 Hz to about 25 Hz, from about 5 Hz to about 10 Hz, from about 10Hz to about 25 Hz, or any other suitable range of frequencies. In someimplementations, the first catheter is moved reciprocally with respectto an adjacent catheter or guidewire such as axially at a reciprocationfrequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5Hz, at least Hz, at least 25 Hz, no more than 0.5 Hz, no more than 1 Hz,no more than 2 Hz, no more than 5 Hz, no more than 10 Hz, no more than25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz,about 25 Hz or any other suitable frequency.

In one implementation, a first catheter is moved reciprocally withrespect to the adjacent catheter or guidewire such as axially over astroke length in a range of from about 0.5 inches to about 10 inches, orfrom about one inch to about 5 inches at a reciprocation frequency of nomore than about 5 cycles per second or two cycles per second or less.

In some implementations, a first catheter is moved reciprocally withrespect to an adjacent catheter or guidewire such as rotationally overan angle of rotation per stroke in a range of from about 5 degrees toabout 180 degrees, from about 5 degrees to about 360 degrees, from about15 degrees to about 180 degrees, from about 15 degrees to about 150degrees, from about 15 degrees to about 120 degrees, from about 15degrees to about 90 degrees, form about degrees to about 60 degrees,from about 15 degrees to about 30 degrees, from about 30 degrees toabout 180 degrees, from about 30 degrees to about 150 degrees, fromabout 30 degrees to about 120 degrees, from about 30 degrees to about 90degrees, form about 30 degrees to about 60 degrees, from about 60degrees to about 180 degrees, from about 60 degrees to about 150degrees, from about 60 degrees to about 120 degrees, from about 60degrees to about 90 degrees, from about 90 degrees to about 180 degrees,from about 90 degrees to about 150 degrees, from about 90 degrees toabout 120 degrees, from about 120 degrees to about 180 degrees, fromabout 120 degrees to about 150 degrees, from about 150 degrees to about180 degrees or any other suitable range. In some implementations, afirst catheter is moved reciprocally with respect to an adjacentcatheter or guidewire such as rotationally over an angle of rotation perstroke of at least 5 degrees, at least 15 degrees, at least 30 degrees,at least 60 degrees, at least 90 degrees, at least 120 degrees, at least150 degrees, at least 180 degrees, at least 360 degrees, no more than 5degrees, no more than 15 degrees, no more than 30 degrees, no more than60 degrees, no more than 90 degrees, no more than 120 degrees, no morethan 150 degrees, no more than 180 degrees, no more than 360 degrees,about 5 degrees, about 15 degrees, about 30 degrees, about 60 degrees,about 90 degrees, about 120 degrees, about 150 degrees, about 180degrees, about 360 degrees, or any other suitable angle.

In some implementations, a first catheter is moved reciprocally withrespect to an adjacent catheter or guidewire such as rotationally at areciprocation frequency in a range of from about 0.5 Hz to about 1 Hz,from about 1 Hz to about 5 Hz, from about 1 Hz to about Hz, from about 1Hz to about 25 Hz, from about 5 Hz to about 10 Hz, from about 10 Hz toabout 25 Hz, or any other suitable range of frequencies. In someimplementations, the first catheter is moved reciprocally with respectto an adjacent catheter or guidewire such as rotationally at areciprocation frequency of at least 0.5 Hz, at least 1 Hz, at least 2Hz, at least Hz, at least 10 Hz, at least 25 Hz, no more than 0.5 Hz, nomore than 1 Hz, no more than 2 Hz, no more than 5 Hz, no more than 10Hz, no more than 25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5Hz, about 10 Hz, about 25 Hz or any other suitable frequency.

In some implementations, a first catheter is moved reciprocally withrespect to an adjacent catheter or guidewire for a number ofreciprocations between 1 and 200, between 1 and 100, between 1 and 50,between 1 and 25, between 1 and 15, between 1 and 10, between 1 and 5,between 5 and 25, between 5 and 15, between 5 and 10, or any othersuitable range. In some implementations, a first catheter is movedreciprocally with respect to an adjacent catheter or guidewire for atleast 1 reciprocation, at least 2 reciprocations, at least 5reciprocations, at least 10 reciprocations, at least 15 reciprocations,at least 25 reciprocations, at least 50 reciprocations, no more than 5reciprocations, no more than 10 reciprocations, no more than 15reciprocations, no more than 25 reciprocations, no more 50 thanreciprocations, no more than 100 reciprocations, no more than 200reciprocations, about 1 reciprocation, about 2 reciprocations, about 5reciprocations, about 10 reciprocations, about 25 reciprocations, about50 reciprocations, about 100 reciprocations, about 200 reciprocations,or any other suitable number. One reciprocation can include a movement(axially or rotationally) from a first position to a second positionfollowed by a return from the second position to the first position.

In some implementations, a first catheter is moved reciprocally withrespect to an adjacent catheter or guidewire over a length of time in arange of from 1 about second to about 60 seconds, from about 1 second toabout 45 seconds, from about 1 second to about 30 seconds, from about 1second to about 20 seconds, from about 1 second to about 15 seconds,from about 1 second to about 10 seconds, from about 5 seconds to about45 seconds, from about 5 seconds to about 30 seconds, from about 5seconds to about 20 seconds, from about 5 seconds to about 15 seconds,from about 5 seconds to about 10 seconds, from about 10 seconds to about30 seconds, form about 10 seconds to about 20 seconds, or any othersuitable range. In some implementations, a first catheter is movedreciprocally with respect to an adjacent catheter or guidewire over alength of time of at least 1 second, at least 5 seconds, at least 10seconds, at least 15 seconds, at least 20 seconds, at least 30 seconds,at least 45 seconds, at least 60 seconds, no more than 5 seconds, nomore than 10 seconds, no more than 15 seconds, no more than 20 seconds,no more than 30 seconds, no more than 45 seconds, no more than 60seconds, about 5 seconds, about 10 seconds, about 15 seconds, about 20seconds, about 30 seconds, about 45 seconds, about 60 seconds, or anyother suitable length of time.

Reciprocation of adjacent catheters to disrupt microbubbles may beaccomplished manually by grasping the corresponding catheter hubs andmanually moving the catheters axially or rotationally with respect toeach other while delivering pressurized saline. Alternatively, such asin a robotically driven system, a processor may be configured torobotically drive at least one of two adjacent catheter hubs (forexample, at least one of hub 2914 and hub 2912) to achieve relativemovement between the adjacent catheters thereby disrupting and expellingmicrobubbles, such as in response to user activation of a flush control.

The reciprocation of adjacent catheters may generate shear forces thatdislodge the air bubbles. In some embodiments, the shear force can beincreased by increasing the flow rate of the solution (e.g., saline)being provided by the fluidics system. In certain embodiments, both flowrate and relative movement between adjacent catheters are controlled todislodge air bubbles.

In some embodiments, after each catheter is primed by the fluidicssystem, an ultrasound bubble detector may be used to confirm that thecatheters are substantially free of air bubbles. For example, anultrasound chip (such as mounted within a hub adjacent a catheterreceiving lumen) may be run along the length of the catheters to confirmthat no air bubbles remain in the system.

An example of a priming process including reciprocal movement ofadjacent catheters is described with respect to FIGS. 21A-21B.

FIG. 21A depicts the interventional device assembly 2900 assembled in aconcentric stack configuration. As shown in FIG. 21A, the interventionaldevices can be fully nested within each other. This may be theconfiguration following unpackaging of the device assembly 2900 andplacement onto the robotic drive table. Alternatively, individualinterventional devices of the device assembly 2900 can be assembled intothe device assembly 2900 on the drive table.

A priming sequence may begin by priming the catheter 2906. In someembodiments, the catheter 2906 can be primed by introducing saline underpressure into the lumen of the catheter 2906 while generating reciprocalmovement of catheter 2906 and/or hub 2914, axially, rotationally orboth, relative to the catheter 2904. Priming the catheter 2906 caninclude priming the hub 2914. For example, in certain embodiments, thehub 2914 or a hemostasis valve coupled thereto can include fluidicsconnections to receive priming fluid from the fluidics system. Incertain embodiments, the catheter 2906 and/or hub 2914 can be axiallyagitated back and forth along a longitudinal axis of the catheter 2906(e.g., between the position of FIG. 21A and the position of FIG. 21B).Axial and/or rotational reciprocal motion of the catheter 2906 and/orhub 2914 can be performed manually or by a robotic drive table.

In some embodiments, priming of the catheter 2906 may be performed byintroducing saline under pressure into the lumen of the catheter 2906while generating reciprocal movement of the catheter 2904 and/or hub2912, axially, rotationally or both, relative to the catheter 2906.Axial and/or rotational reciprocal motion of the catheter 2904 and/orhub 2912 can be performed manually or by a robotic drive table.

In some embodiments, priming of the catheter 2906 may be performed byintroducing saline under pressure into the lumen of the catheter 2906while generating reciprocal movement of both the catheter 2906 (and/orhub 2914) and the catheter 2904 (and/or hub 2912), axially, rotationallyor both, relative to one another.

In some embodiments, after priming the catheter 2906, the catheter 2906can be returned to an initial position as shown in FIG. 21A.

In some embodiments, after the catheter 2906 is primed, the catheter2904 can be primed. Priming the catheter 2904 can include priming thehub 2912. For example, in certain embodiments, the hub 2912 or ahemostasis valve coupled thereto can include fluidics connections toreceive priming fluid from the fluidics system. In some embodiments, thecatheter 2904 can be primed by introducing saline under pressure intothe lumen of the catheter 2904 while generating reciprocal movement ofthe catheter 2904 and/or hub 2912, axially, rotationally or both,relative to the catheter 2902.

In some embodiments, priming of the catheter 2904 may be performed byintroducing saline under pressure into the lumen of the catheter 2904while generating reciprocal movement of the catheter 2902 and/or hub2910, axially, rotationally or both, relative to the catheter 2904.Axial and/or rotational reciprocal motion of the catheter 2902 and/orhub 2910 can be performed manually or by a robotic drive table.

In some embodiments, priming of the catheter 2904 may be performed byintroducing saline under pressure into the lumen of the catheter 2904while generating reciprocal movement of both the catheter 2904 (and/orhub 2912) and the catheter 2902 (and/or hub 2910), axially, rotationallyor both, relative to one another.

In some embodiments, after priming the catheter 2904, the catheter 2904can be returned to an initial position as shown in FIG. 21A.

In some embodiments, after the catheter 2904 is primed, the catheter2902 can be primed. Priming the catheter 2902 can include priming thehub 2910. For example, in certain embodiments, the hub 2910 or ahemostasis valve coupled thereto can include fluidics connections toreceive priming fluid from the fluidics system. In some embodiments, thecatheter 2902 can be primed by introducing saline under pressure intothe lumen of the catheter 2902 while generating reciprocal movement ofthe catheter 2902 and/or hub 2910, axially, rotationally or both,relative to the guidewire 2907.

In some embodiments, priming of the catheter 2902 may be performed byintroducing saline under pressure into the lumen of the catheter 2902while generating reciprocal movement of the guidewire 2907 and/or hub2909, axially, rotationally or both, relative to the catheter 2902.Axial and/or rotational reciprocal motion of the guidewire 2907 and/orhub 2909 can be performed manually or by a robotic drive table.

In some embodiments, priming of the catheter 2902 may be performed byintroducing saline under pressure into the lumen of the catheter 2902while generating reciprocal movement of both the catheter 2902 (and/orhub 2910) and the guidewire 2907 (and/or hub 2909), axially,rotationally or both, relative to one another.

In some embodiments, after priming the catheter 2902, the catheter 2902can be returned to an initial position as shown in FIG. 21A.

In the priming sequence described herein with respect to FIGS. 21A and21B, the catheters are primed in order starting with the catheter 2906,followed by the catheter 2904, and then followed by the catheter 2902.However, it is contemplated that the catheters may be primed in anyorder. The catheters may be primed in series as described above withrespect to FIGS. 21A and 21B. Alternatively, two or more of thecatheters or each of the catheters may be primed in parallel.

In certain embodiments, priming the catheters can include decreasing adepth of axial insertion (i.e., axial overlap) of a secondinterventional device into the lumen of a first interventional devicethrough which fluid is to be injected (e.g., a length of the secondinterventional device into its concentrically adjacent lumen), asdescribed with respect. to FIGS. 20A-20C, and also generating relativereciprocal movement, axially, rotationally or both, between firstinterventional device and the second interventional device duringpriming, as discussed with respect to FIGS. 21A and 21B.

EXAMPLES

Additional embodiments are disclosed in further detail in the followingexamples, which are not in any way intended to limit the scope of theclaims.

FIG. 22 is a diagram of a test system that was used for detecting theremoval of air bubbles between concentrically stacked catheters. Thetest system included an inner catheter 2108 positioned within aninterior lumen of an outer catheter 2106 in a concentric stack. Theouter catheter 2106 was coupled to a rotating hemostasis valve 2104. Thehemostasis valve 2104 was coupled to a syringe 2102 so that fluidinjected using the syringe would flow through the lumen between theinner catheter 2108 and the outer catheter 2016. In the test system, theinner catheter 2108 had a diameter of about 0.071 inches. The outercatheter 2106 had a diameter of about 0.088 inches. The outer catheter2106 was transparent to permit visualization of bubbles within thelumen. A distal end of the outer catheter 2108 allowed for small volumesof fluid to exit the outer catheter. FIG. 23A is a photograph showingthe catheter 2106 and catheter 2108 in a concentric stack, prior toinjection of fluid.

Example 1

In a first example, the syringe 2102 was used to inject water at aconstant pressure of about 150 psi through the hemostasis valve 2104without moving the catheter 2106 or the catheter 2108. FIG. 23B is aphotograph showing the catheter 2106 and catheter 2108 following theinjection of water. As shown in FIG. 23B, bubbles are present within thelumen between the catheter 2106 and the catheter 2108.

Example 2

In a second example, the syringe 2102 was used to inject water at aconstant pressure of about 150 psi through the hemostasis valve 2104.Shortly after beginning to inject water, axial reciprocal movement ofthe inner catheter 2108 was performed for about 10 seconds. Thereciprocal movement was performed at a frequency of about 1 Hz (or less)and a stroke length of about 20 mm (or more). FIG. 23C is a photographshowing the catheter 2106 and the catheter 2108 following the axialreciprocal movement. As shown in FIG. 23C, the lumen between thecatheter 2106 and the catheter 2108 was substantially free of bubbles.

Example 3

In a third example, an outer catheter having a diameter of about 0.071inches and an inner catheter having a diameter of about 0.035 incheswere used in the test system 2100 instead of the outer catheter 2106 andthe inner catheter 2108 described with respect to Examples 1 and 2. Asyringe 2102 was used to inject water at a constant pressure of about150 psi through a hemostasis valve 2104 coupled to the outer catheter.Shortly after beginning to inject water, axial reciprocal movement ofthe inner catheter was performed for about 10 seconds. The reciprocalmovement was performed at a frequency of about 1 Hz (or less) and astroke length of about 20 mm (or more). Following the axial reciprocalmovement, the lumen between the outer and inner catheters was found tobe substantially free of bubbles by visual inspection.

While the foregoing describes robotically driven interventional devicesand manually driven interventional devices, the devices may be manuallydriven, robotically driven, or any combination of manually androbotically driven interventional devices, as will be appreciated bythose of skill in the art in view of the disclosure herein.

The foregoing represents one specific implementation of a roboticcontrol system. A wide variety of different robotic control systemconstructions can be made, for supporting and axially advancing andretracting two or three or four or more assemblies to robotically driveinterventional devices, as will be appreciated by those of skill in theart in view of the disclosure herein.

Various systems and methods are described herein primarily in thecontext of a neurovascular access or procedure (e.g.,neurothrombectomy). However, the catheters, systems (e.g., drivesystems), and methods disclosed herein can be readily adapted for any ofa wide variety of other diagnostic and therapeutic applicationsthroughout the body, including particularly intravascular proceduressuch as in the peripheral vasculature (e.g., deep venous thrombosis),central vasculature (pulmonary embolism), and coronary vasculature, aswell as procedures in other hollow organs or tubular structures in thebody.

What is claimed is:
 1. A method of achieving supra aortic access,comprising the steps of: providing an assembly comprising: a guidewire,an access catheter and a guide catheter, coaxially moveably assembledinto a single multi-catheter assembly; coupling the assembly to a drivesystem; driving the assembly to an aortic arch; and advancing the accesscatheter to achieve supra-aortic access to a branch vessel off of theaortic arch.
 2. The method of claim 1, further comprising driving asubset of the assembly to an intracranial site, and performing aneurovascular procedure using the subset of the assembly.
 3. The methodof claim 2, wherein the subset comprises the guidewire, the guidecatheter, and a procedure catheter.
 4. The method of claim 3, whereinthe procedure catheter is an aspiration catheter.
 5. The method of claim3, wherein the procedure catheter is an embolic deployment catheter. 6.The method of claim 3, wherein the procedure catheter is a stentdeployment catheter.
 7. The method of claim 3, wherein the procedurecatheter is a flow diverter deployment catheter.
 8. The method of claim3, wherein the procedure catheter is a diagnostic angiographic catheter.9. The method of claim 3, wherein the procedure catheter is a stentretriever catheter.
 10. The method of claim 3, wherein the procedurecatheter is a clot retriever.
 11. The method of claim 3, wherein theprocedure catheter is a balloon catheter.
 12. The method of claim 3,wherein the procedure catheter is a catheter to facilitate percutaneousvalve repair or replacement.
 13. The method of claim 3, wherein theprocedure catheter is an ablation catheter.
 14. The method of claim 2,wherein the intracranial procedure comprises an intracranialthrombectomy.
 15. The method of claim 2, wherein the neurovascularprocedure comprises a neurovascular thrombectomy.
 16. The method ofclaim 1, wherein at least one of the guidewire, the access catheter, andthe guide catheter comprises a hub configured to couple to a roboticdrive system.
 17. The method of claim 16, wherein coupling the assemblyto the drive system comprises magnetically coupling a guide catheter hubto the drive system.
 18. The method of claim 16, wherein coupling theassembly to the drive system comprises mechanically coupling a guidecatheter hub to the drive system.
 19. The method of claim 18, whereinthe drive system is a robotic drive system, and at least a first drivemagnet, a second drive magnet, and a third drive magnet are eachindependently movably carried by a drive table associated with therobotic drive system.